Pharmacovigilance Jobs

Roles & ResponsibilitiesICSR Processing & Case Review• Perform end-to-end ICSR processing in accordance with SOPs and project safety plans• Conduct quality review of ICSRs to ensure completeness and regulatory compliance• Perform medical coding of adverse events, medical history, concomitant medications, and laboratory data using MedDRA and relevant dictionaries• Prepare comprehensive and medically accurate narrative summaries• Manage follow-up queries to obtain complete and accurate case information• Identify and manage duplicate ICSRsRegulatory Reporting & Compliance• Support xEVMPD validation and submission activities• Contribute to SPOR / IDMP-related initiatives• Maintain safety tracking logs and ensure timely regulatory submissions• Support audit readiness and regulatory inspection activities• Ensure adherence to SOPs, GVP, ICH-GCP, and global safety regulations• Assist in clinical trial and post-marketing safety reporting activitiesQualification• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / PharmD / BDS / BMS / MBBS(B.Sc / M.Sc not eligible)Experience• 2.5 – 4 years of pharmacovigilance experience• Minimum 1 year of exclusive Product Quality Complaint (PQC) case handling• Experience in medical research safety cases• Hands-on experience with Argus / ARISg safety database• Experience in clinical trial and/or post-marketing safety reportingSkills • Strong understanding of global pharmacovigilance regulations• Excellent organizational and prioritization skills• High level of accuracy with strong compliance focus• Effective stakeholder coordination and communication abilities• Ability to work in a deadline-driven environment• Proficiency in Microsoft Office applicationsAbout the CompanySyneos Health is a global biopharmaceutical solutions organization operating across 110+ countries, supporting clinical development, medical affairs, and commercialization services worldwide.

Roles & ResponsibilitiesICSR Processing & Case Management• Enter and track ICSRs in PVG quality and tracking systems• Process ICSRs as per SOPs and project-specific safety plans• Triage cases for completeness, accuracy, and regulatory reportability• Perform data entry in Argus / ARISg safety database• Code adverse events, medical history, concomitant medications, and lab data using MedDRA and relevant dictionaries• Prepare medically accurate narrative summaries• Identify missing or inconsistent information and follow up for resolution• Detect and manage duplicate cases• Conduct quality review of processed ICSRsRegulatory Reporting & Compliance• Support preparation and submission of expedited safety reports as per global regulatory timelines• Validate and submit xEVMPD product records with appropriate MedDRA coding• Perform manual recoding of product and substance terms from ICSRs• Support SPOR / IDMP-related activities• Maintain safety tracking logs for assigned activities• Ensure submission of documents to TMF (clinical trials) and PSMF (post-marketing programs)• Apply global safety regulatory intelligence to reporting activitiesLiterature, Audit & Collaboration• Perform literature screening and safety reviews• Maintain drug dictionaries and support coding updates• Ensure compliance with SOPs, WIs, GCP, ICH, GVP, and global safety regulations• Participate in audits and support inspection readiness activities• Collaborate effectively with internal and external stakeholdersQualification• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy) / PharmD (Doctor of Pharmacy) / BDS / BMS / MBBS(B.Sc /M.Sc not eligible)Experience• 2.5 – 4 years of pharmacovigilance experience• Minimum 1 year of exclusive Product Quality Complaint (PQC) case handling• Experience in medical research-related safety cases• Hands-on experience with Argus / ARISg safety database• Knowledge of Clinical Trial Phases II–IV and/or post-marketing safetySkills• Strong understanding of global pharmacovigilance regulations and reporting requirements• Proficiency in Microsoft Office applications• Strong analytical and documentation skills• Excellent communication and stakeholder coordination abilities• High attention to detail and compliance-focused approachAbout the CompanySyneos Health is a global biopharmaceutical solutions organization operating in 110+ countries, supporting clinical development, medical affairs, and commercialization services worldwide.

Roles & Responsibilities• Create and manage ICSR case identification and data entry• Perform MedDRA coding and case processing activities• Ensure accurate entry of safety data into pharmacovigilance databases• Handle case submissions in compliance with regulatory requirements• Conduct follow-ups for incomplete or pending safety cases• Work in alignment with global pharmacovigilance guidelines and SOPs• Process routine drug safety cases as per defined procedures• Collaborate within the pharmacovigilance team and report to supervisor• Support drug safety surveillance and regulatory adherence initiativesQualification• MSc (Life Sciences) / B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy)Experience• 0–1 year experience in Pharmacovigilance• Freshers eligibleSkills• Basic understanding of Adverse Event (AE) reporting• Knowledge of ICSR lifecycle and case processing• Familiarity with MedDRA terminology• Awareness of drug safety database concepts• Strong attention to detail and data accuracy• Ability to work in rotational shifts• Good written and verbal communication skills• Team-oriented and compliance-focused mindsetAbout the OrganizationAccenture is a global professional services company providing consulting, technology, and operations services, including pharmacovigilance and drug safety support to leading pharmaceutical and healthcare organizations worldwide.

Roles & Responsibilities:• Manage Product Life Cycle Management (LCM) activities in line with regulatory guidelines• Ensure compliance with applicable regulatory requirements and internal SOPs• Maintain and update internal regulatory databases and tracking systems• Keep regulatory archives updated with valid licenses, approvals, and labelling documents• Coordinate with internal and external stakeholders for change management activities• Assist in electronic formatting and compilation of global regulatory submissions (eCTD)• Support preparation and review of global filing documentation as per agency guidance• Perform documentation control, archival, and administrative regulatory tasks• Support regulatory submissions in compliance with ICH and EU requirementsQualification:• Bachelor degree in Pharmacy, Master of Pharmacy• Bachelor’s Degree in Science from a reputed College/UniversityExperience:• 2–3 years of experience in Regulatory Affairs or regulated pharmaceutical industrySkills:• Knowledge of Product Lifecycle Management (PLM)• Understanding of EU regulatory requirements and ICH guidelines• Experience in eCTD submissions and electronic publishing• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)• Strong documentation, tracking, and archival skills• Familiarity with regulatory software systems• Ability to work independently and collaboratively in cross-functional teams• Fluency in English (written and verbal communication)About the Organization:Orion Pharma is a globally operating pharmaceutical organization focused on delivering innovative and high-quality medicines while maintaining strong regulatory compliance across international markets.

Roles & Responsibilities:• Perform data entry of adverse event reports into the pharmacovigilance (PV) database• Assess seriousness and causality of adverse event cases as per regulatory guidelines• Validate data against source documents and call notes for accuracy• Ensure completeness, correctness, and quality of cases prior to regulatory submission• Identify potential delays in case processing and escalate issues appropriately• Determine need for follow-up information and ensure timely case closure• Comply with internal and global timelines for adverse event and product complaint processing• Maintain adherence to global and local pharmacovigilance regulations• Meet expected productivity and quality benchmarks• Actively participate in team meetings and support assigned PV activitiesQualification:• Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience OR• Bachelor’s degree in Life Sciences with 0–2 years of pharmacovigilance experience• Bachelor of Pharmacy, Master of Pharmacy, Docotor of PharmacyExperience:• 0–2 years of experience in pharmacovigilance / adverse event case processing preferredSkills:• Basic knowledge of medical terminology relevant to pharmacovigilance• Understanding of global and local regulatory requirements• Strong attention to detail and data accuracy• Effective written and verbal communication skills• Ability to manage multiple products and priorities simultaneously• Proficiency in working with multiple databases• Flexibility to manage high-volume case processing• Self-motivated and adaptable to dynamic environmentsAbout the Organization:Elanco is a global leader in animal health dedicated to innovation in preventing and treating diseases in farm animals and pets, fostering a diverse and inclusive culture focused on improving animal health worldwide.

Roles & Responsibilities• Perform medical review of ICSRs ensuring accuracy, medical relevance, and consistency with source documents• Evaluate adverse events (AE) and serious adverse events (SAE) for seriousness, listedness, and completeness• Conduct company causality assessments aligned with global pharmacovigilance regulations• Review case narratives, coding, labeling, product/indication details, and medical history for completeness and accuracy• Provide medical sign-off on safety cases• Conduct line listing review of non-serious cases and verify coding and labeling accuracy• Perform unblinding activities as applicable• Ensure appropriate follow-up questionnaires are initiated when required• Conduct literature surveillance when applicable• Review Analyses of Similar Events (AOSE) for expedited regulatory cases• Provide aggregate safety reviews including clinical, post-marketing, and literature data• Track inconsistencies identified during data entry and QC review and provide quality improvement feedback• Contribute to safety surveillance strategies and risk management planning• Review safety assessments and benefit-risk evaluations from a medical perspective• Author and update SOPs and support global quality and compliance initiatives• Communicate findings to stakeholders and ensure RCA/CAPA implementation• Present QA and safety data in governance and internal review meetings• Ensure compliance with international pharmacovigilance regulations and company SOPsQualification• Degree in Medicine (MBBS preferred)• Strong knowledge of disease pathology, physiology, pharmacology, and therapeutics• Sound understanding of pharmacovigilance safety databases and compliance processesExperience• 1+ years experience in Drug Safety / Pharmacovigilance• Prior experience in medical review of ICSRs preferred• Exposure to global pharmacovigilance regulations desirableSkills• Strong analytical and critical thinking ability• High attention to detail and scientific accuracy• Good verbal reasoning and comprehension skills• Effective communication and interpersonal skills• Ability to meet deadlines and maintain quality standards• Knowledge of drug development and pharmacovigilance processes• Mentoring and training capabilityAbout the CompanyIndegene is a global healthcare solutions company that partners with life sciences and pharmaceutical organizations to drive commercialization, medical affairs, pharmacovigilance, and digital transformation initiatives. The company combines medical expertise, technology, and analytics to support drug development, safety monitoring, and patient-centric healthcare solutions worldwide.

Roles & Responsibilities• Critically analyze biomedical literature for identification of Individual Case Safety Reports (ICSRs)• Identify adverse events and other safety-relevant information from published sources• Perform literature monitoring in line with global regulatory requirements• Write clear and concise safety narratives summarizing ICSR criteria• Review drug labels and therapeutic area information for safety assessment• Ensure timely and accurate drug safety review and reporting• Maintain audit-ready documentation within drug safety databases• Adhere strictly to SOPs and pharmacovigilance compliance standards• Support quality checks and internal review processes• Contribute to continuous improvement in literature screening workflowsQualification• Master’s Degree in Pharmacy, Microbiology, Biotechnology, Biochemistry, Biophysics, Life Sciences, or Biomedical SciencesExperience• Fresher or up to 2 years of experience in biomedical literature review for adverse event reporting• Experience in pharmacovigilance literature screening (preferred)Skills• Strong understanding of biomedical and medical terminology• Knowledge of pharmacovigilance regulations and safety reporting requirements• Analytical thinking and summarization skills• Familiarity with literature databases such as PubMed and Embase• Excellent written and verbal English communication skills• Strong time management and adherence to SOPs• High attention to detail and documentation accuracyAbout the OrganizationClarivate is a global information services provider supporting innovation across life sciences, healthcare, academia, and intellectual property. Through advanced analytics, scientific data solutions, and regulatory intelligence services, Clarivate helps organizations accelerate research, ensure compliance, and make informed decisions in drug safety and pharmacovigilance operations.

Roles & Responsibilities• Identify and create safety cases in global safety databases• Perform triage, case prioritization, and processing of AEs, SAEs, and SUSARs• Conduct medical coding using MedDRA and WHO-Drug Dictionary (WHODD)• Perform data entry and narrative writing in global safety systems• Assess seriousness and causality as per client SOPs• Submit safety reports within defined regulatory timelines• Conduct duplicate checks and validation of case data• Follow up for missing or incomplete safety information• Handle E2B submissions and regulatory reporting requirements• Translate source documents and case narratives where required• Participate in audits and regulatory inspections• Perform mailbox reconciliation and safety data tracking• Ensure strict adherence to global pharmacovigilance regulations and compliance frameworksQualification• B.Pharm (Bachelor of Pharmacy)• BSc Nursing• Bachelor’s Degree in Life SciencesExperience• 0–1 year of experience in Pharmacovigilance or Drug Safety (Freshers can apply)• Basic understanding of global safety reporting requirementsSkills• Knowledge of Pharmacovigilance and Drug Safety processes• Familiarity with safety databases and case processing workflows• Understanding of MedDRA and WHO-Drug coding• Proficiency in MS Office applications• Strong English communication and medical writing skills• High attention to detail and accuracy• Ability to meet strict timelines and quality KPIsAbout the OrganizationAccenture is a global professional services company specializing in digital, technology, and operations solutions. With a strong presence in life sciences and healthcare, Accenture supports global pharmaceutical companies through pharmacovigilance operations, regulatory compliance, and drug safety surveillance services.

Roles & Responsibilities• Perform safety surveillance, signal detection, risk minimization, and safety data evaluation• Author, review, and support delivery of aggregate safety reports (ASRs), DSURs, and PSURs• Draft safety management plans and signal detection plans• Support internal and client-facing safety strategy development• Prepare and update regulatory safety documents including RMPs, REMS, and CCDS/CCSI• Review safety sections of study protocols and assess ICSRs for completeness and accuracy• Maintain pharmacovigilance system master file (PSMF) and related documentation• Define search strings and conduct safety-related literature searches and analysis• Generate reports to support EMA medical literature monitoring requirements• Collaborate with cross-functional teams to ensure accurate source data review and analysisQualification• B.Pharm / M.Pharm• Life Sciences (Biochemistry, Biotechnology, Pharmacology, Microbiology)• Biomedical Science, Nursing, Chemistry, BiologyExperience• 3 to 7 years of pharmacovigilance / drug safety / clinical trials experience• Strong understanding of global PV regulations and guidelines (ICH-GCP, EMA, USFDA)• Experience in data analysis, document review, and cross-functional stakeholder communicationSkills• Safety signal detection and risk management• Aggregate report writing (DSUR, PSUR/PBRER, ASR)• Regulatory safety documentation (RMP, REMS, CCDS/CCSI)• ICSR and protocol safety section review• PSMF maintenance and PV compliance documentation• Medical literature search strategy, analysis, and reporting• Strong written communication and stakeholder managementAbout The CompanyICON plc is a global clinical research organization supporting drug development and lifecycle management across therapeutic areas. ICON partners with sponsors to deliver clinical trials and pharmacovigilance solutions, with a focus on quality, regulatory compliance, and patient safety worldwide.

Roles & ResponsibilitiesSafety Medical Writing & Aggregate Reporting• Lead preparation of scheduled and ad-hoc aggregate safety reports such as PSUR, PBRER, DSUR, PADER, SASR, ARBE, and safety statements• Independently manage simple reports and support medium-complexity reports under supervision• Compile, analyze, and present safety data following regulatory templates and guidance• Incorporate team review feedback and perform quality checks for consistency and data integrity• Coordinate submission of safety documents to global regulatory authorities• Prepare supporting documentation including labeling comparison documents, INN checks, and appendices• Ensure timely delivery of high-quality regulatory safety documentsSafety Analysis & Signal Management• Perform signal detection activities using safety databases, literature, clinical data, and regulatory sources• Conduct quantitative and qualitative safety data analyses to identify potential signals• Maintain and update signal tracking logs with minimal supervision• Support safety evaluation activities for products with established safety profiles• Prepare and contribute to Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs)• Conduct literature searches and summarize findings for safety evaluations and epidemiology reports• Identify and resolve discrepancies in safety data listings and source documentsRisk Management• Assist in preparation and maintenance of Risk Management Plans (RMPs)• Ensure accuracy, completeness, and consistency of risk-related documentation• Support updates to risk minimization measures and safety communicationsGeneral Scientific & Operational Support• Maintain working knowledge of assigned product safety profiles and therapeutic areas• Apply proficiency in medical terminology and pharmacovigilance coding dictionaries (MedDRA, WHO-DD)• Deliver high-quality outputs through detailed self-review and structured quality checks• Contribute to safety discussions with evidence-based insights• Communicate proactively regarding task progress, timelines, and challenges• Prioritize multiple deliverables and consistently meet deadlines• Maintain audit-ready documentation and ensure proper archiving• Support inspection readiness and compliance activitiesClient Engagement & Collaboration• Manage routine client communications and respond to queries independently• Escalate complex issues appropriately• Provide proactive status updates and manage document review cycles• Adapt to client-specific templates and regulatory requirements• Collaborate cross-functionally in global team environmentsQuality Control & Compliance• Ensure deliverables meet global pharmacovigilance regulatory requirements• Perform quality control checks and support oversight of junior team members• Monitor KPIs and SLAs to ensure project timelines are met• Participate in audit and compliance readiness activities• Contribute to continuous process improvement initiativesLearning & Innovation• Complete advanced training programs and support team capability development• Utilize safety databases, writing tools, and MS Office applications effectively• Adapt to new technologies and support automation or process improvementsQualification• Bachelor’s or Master’s degree in Life Sciences / Health / Biomedical Sciences• Preferred fields: Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy or related discipline• Master's of Pharmacy, Doctor of PharmacyExperience• Prior experience in pharmacovigilance or drug safety preferred• Understanding of global pharmacovigilance regulations and safety concepts• Clinical or hospital-based exposure advantageousSkills• Strong analytical thinking and problem-solving ability• Scientific writing expertise with regulatory compliance focus• Proficiency in MS Office and medical writing tools• Familiarity with pharmacovigilance databases and coding dictionaries (MedDRA, WHO-DD)• Excellent organizational and time management skills• Strong collaboration and interpersonal communication skills• Ability to manage multiple projects and meet strict deadlines• Adaptability and continuous learning mindsetAbout the OrganizationParexel is a leading global clinical research organization (CRO) that provides comprehensive drug development and regulatory consulting services to the pharmaceutical, biotechnology, and medical device industries. With a strong focus on patient safety, innovation, and regulatory excellence, Parexel offers a collaborative and growth-oriented environment for professionals in pharmacovigilance and medical writing.

Role & Responsibilities• Solve routine problems with reference to general guidelines.• Interact primarily within your own team and with your direct supervisor.• Follow detailed to moderate level instructions on daily tasks and new assignments.• The decisions made will impact your own work.• Work as an individual contributor as part of a team, with a focused scope of work.• May require working in rotational shifts.Qualification• Bachelor of Pharmacy / Master of Pharmacy.Experience• 1 to 3 years of experience in pharmacovigilance or drug safety operations.Vacancies• 1 VacancySkills• Proficiency in pharmacovigilance and drug safety surveillance.• Experience with case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs.• Understanding of global regulatory requirements related to pharmacovigilance.• Ability to monitor and assess the safety of pharmaceutical products.• Familiarity with clinical trials data and healthcare provider data analysis.• Ability to solve routine problems through guidelines.About The CompanyAccenture is a global professional services company with leading capabilities in digital, cloud, and security. The company offers strategy and consulting, technology and operations services, and Accenture Song.

Roles & Responsibilities:• Develop and implement global regulatory strategies for Drugs and Medical Devices across product lifecycle (Initial registrations, Geo-expansion, Variations, Change Controls, Tender support, Legal entity updates, etc.)• Lead global lifecycle management submissions ensuring timely approvals and compliance across multiple markets• Drive regulatory transformation and innovation initiatives to enhance operational efficiency• Establish and standardize regulatory processes, SOPs, and documentation within Central RA• Ensure audit readiness and compliance with global regulatory standards• Collaborate with R&D, Clinical, Quality, Manufacturing, Legal, and Commercial teams to integrate regulatory requirements into business strategy• Monitor global regulatory intelligence and proactively address evolving regulatory changes• Represent the organization before health authorities, regulatory agencies, and industry associations• Identify compliance risks and implement remediation strategies• Lead, mentor, and develop high-performing regulatory teams fostering a strong performance culture• Act as a strategic advisor to senior management on regulatory risks, trends, and opportunitiesQualification:• Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.pharm) • Advance degree of Life Sciences, Biotechnology, Regulatory Affairs, or related fieldExperience:• 12+ years of experience in Global Regulatory Affairs (Pharma / Biotech / Medical Devices)• Extensive experience in global regulatory submissions and lifecycle management• Experience handling both drug and device regulatory requirements• Exposure to regulatory transformation and process harmonization initiatives• Strong track record of successful approvals across global marketsSkills:• Strong knowledge of global regulatory agencies such as US FDA, EMA, MHRA, TGA, and ICH guidelines• Proven leadership and people management experience• Advanced knowledge of global regulatory frameworks and compliance requirements• Strategic thinking with strong problem-solving ability• Strong leadership, stakeholder management, and cross-functional collaboration skills• Ability to manage complex regulatory environments across diverse markets• Strong project management and organizational skills• Excellent communication and presentation skills• Ability to drive innovation and continuous improvement in regulatory operationsAbout the Organization:Baxter International is a global healthcare leader committed to saving and sustaining lives. Founded in 1931, the company delivers innovative medicines and medical products worldwide, driven by a strong culture of integrity, collaboration, and patient-focused innovation.

Roles & Responsibilities:• Ensure end-to-end governance and compliant execution of Patient Support Programs (PSP) and Primary Marketing Research (PMR) programs• Conduct programs in alignment with approved SOPs and defined governance standards• Support Global Business Owners in initiation and implementation of PSP and PMR programs• Oversee end-to-end coordination of global programs, ensuring stakeholder engagement across regions and functions• Ensure completion of mandatory ESP training on Adverse Event (AE) reporting prior to field activities• Verify that all required assessments, approvals, and local working practices are followed• Collaborate with SQA Manager, CPSR, Program Advisor, and Global Commercial Governance teams for compliant execution• Act as the primary point of contact for Program Owners for execution-related queries and issue resolution• Manage smooth transition of responsibilities during change of Program Owners to ensure business continuity• Monitor program performance metrics and regulatory adherenceQualification:• Bachelor’s degree in Life Sciences, Pharmacy (Bachelor of Pharmacy / Master of Pharmacys), Biotechnology, or related scientific field• Bachelor’s or Master’s degree in Business Administration (BBA / MBA) or related discipline (preferred for commercial governance exposure)Experience:• Experience in Patient Support Programs (PSP), Commercial Governance, Compliance, or Pharmaceutical Operations preferred• Exposure to global stakeholder coordination and cross-functional program management• Experience working within regulated pharmaceutical environments• Familiarity with governance documentation and process controlsSkills:• Strong understanding of pharmaceutical governance, compliance, and SOP-driven environments• Knowledge of pharmacovigilance requirements and Adverse Event (AE) reporting processes• Strong stakeholder management and cross-functional coordination skills• Excellent communication and presentation abilities• Knowledge of pharmacovigilance and AE reporting frameworks• Analytical thinking and process documentation skills• Strategic marketing and commercial awareness• Ability to manage multiple programs and meet defined performance metrics• Adaptability in dynamic, global environmentsAbout the Organization:Sandoz is a global leader in sustainable generic and biosimilar medicines, providing over 900 million treatments annually across 100+ countries. With a strong focus on accessibility, innovation, and quality, the company is committed to expanding global access to affordable healthcare while fostering a collaborative and growth-oriented work culture.

Roles & Responsibilities:• Compile, review, and author CTD and eCTD dossiers for global submissions• Perform eCTD publishing and manage submission sequences and lifecycle operations• Handle product lifecycle activities including variations, renewals, amendments, and compliance updates• Ensure compliance with current regulatory guidelines and country-specific requirements• Coordinate with QA, CMC, Clinical, Pharmacovigilance, and Medical Writing teams• Communicate with Health Authorities and manage deficiency responses• Track submission timelines, approvals, and regulatory commitments• Maintain regulatory databases and documentation• Support audits, inspections, and internal regulatory assessmentsQualification:• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related disciplineExperience:• 4–6 years of experience in Regulatory Affairs (Pharma/Life Sciences)• Strong hands-on experience in CTD and eCTD compilation and publishing• Experience with US, EU, and ROW regulatory submissions• Experience in lifecycle management and Health Authority interactionsSkills:• Strong knowledge of global regulatory frameworks• eCTD publishing expertise• Good documentation and communication skills• Ability to manage multiple submissions independently• Detail-oriented with compliance-focused mindsetAbout the Organization:Medifodil Smart Pharma Solutions provides regulatory consulting and dossier management services, supporting global pharmaceutical companies in regulatory submissions and product lifecycle management across multiple markets.

Role & Responsibilities• Review biomedical literature for adverse reaction reports (ICSR/Non-ICSR)• Perform relevancy assessments and MedDRA coding• Draft high-quality medical narratives• Mentor scanning teams on inclusion/exclusion criteriaQualification• MBBS/MD (MCI Registered / FMGE cleared)Experience• 1–3 years in Pharmacovigilance (Mandatory)Skills• Strong understanding of pharmacovigilance and drug safety processes• Proficiency in MedDRA coding and adverse event reporting• Excellent medical writing and narrative drafting skills• Ability to mentor and guide team members• Strong attention to detail and data accuracyAbout the CompanyOur client is a global player in the pharmaceutical and healthcare space, committed to ensuring the safety of medicines and protecting patient health through robust pharmacovigilance practices. As a Medical Reviewer in their team, you will have an opportunity to impact drug safety strategies in a fast-paced and dynamic environment.

Roles & Responsibilities• Assist in processing and reviewing Individual Case Safety Reports (ICSRs)• Perform case intake, data entry, and quality review in safety databases• Conduct adverse event (AE) and serious adverse event (SAE) assessments• Support medical coding using MedDRA and WHO-DD• Assist in case narratives, follow-ups, and reconciliation activities• Ensure compliance with global regulatory timelines and SOPs• Support safety reporting, audits, and inspection readiness• Collaborate with cross-functional teams (Clinical, Regulatory, QA)Qualification• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or related fieldExperience• 0–4 years of experience in pharmacovigilance or a related fieldSkills• Strong attention to detail and data accuracy• Basic knowledge of safety databases and Microsoft Excel / MS Office• Understanding of pharmacovigilance concepts and drug safety lifecycle• Strong documentation and organizational skills• Good written and verbal communication skillsAbout the CompanyWe are a global leader providing specialized services in Drug Safety and Pharmacovigilance. This entry-level role offers a fantastic opportunity to kickstart your career in a regulated clinical research environment while supporting critical pharmacovigilance activities for our USA-based client.

Roles & Responsibilities• Signal detection and management within pharmacovigilance processes• Preparation of aggregate safety reports• Collaborating with other teams for safety data analysis and reporting• Providing medical and scientific support for drug safety assessments• Ensuring regulatory compliance and timely submission of safety reportsQualification• MBBS/MD with 1+ years of experience in Pharmacovigilance (PV)Experience• Minimum 1+ years of experience in pharmacovigilanceSkills• Strong expertise in signal detection and safety reporting• Proficient in MedDRA coding and causality assessment• Familiarity with global pharmacovigilance regulations• Excellent communication and teamwork skills• Ability to manage timelines and prioritize tasks effectivelyAbout the CompanyAccenture is a global leader in providing consulting, technology, and outsourcing services. With a strong focus on driving innovation and delivering impactful results, Accenture’s Pharmacovigilance department supports global healthcare initiatives to ensure the safety and efficacy of medicines. We are committed to shaping the future of healthcare through cutting-edge solutions and scientific excellence.

Roles & Responsibilities:• Perform end-to-end ICSR processing and case validation• Receive and review adverse event reports from HCPs, patients, literature, and call centers• Validate cases as per minimum reporting criteria• Enter and manage data in safety databases (Argus, ARISg, Veeva Safety, etc.)• Conduct duplicate checks and follow up for missing safety information• Perform MedDRA coding for adverse events• Assess seriousness, expectedness, and causality as per SOPs• Ensure compliance with global regulatory timelines• Submit cases for medical review and maintain proper documentationQualification:• Bachelor of Pharmacy (mandatory)Experience:• Minimum 1+ year of experience in Drug Safety / Pharmacovigilance• Hands-on experience in ICSR processing• Practical exposure to Argus SafetySkills:• Strong knowledge of pharmacovigilance workflows and ICSR lifecycle• Expertise in MedDRA coding and safety database systems• Understanding of global PV guidelines and regulatory timelines• Attention to detail and strong documentation skillsAbout the Organization:Infomerica is a leading staffing consultancy specializing in IT and healthcare recruitment. The company connects skilled professionals with global organizations, supporting structured and compliance-driven pharmacovigilance operations.

Role & Responsibilities• Perform ICSR processing: duplicate search, validation, data entry, drug/MedDRA coding• Conduct listedness, causality, and expedited reporting assessments• Write clear, accurate narratives for ICSRs• Prepare, revise, and review SOPs, work instructions, and training materials• Report urgent safety issues promptly to Line Manager and QPPV• Maintain professional communication and accurate correspondence records• Ensure 100% regulatory compliance and timely case processing• Deliver training to new joiners and support team members• Stay updated on regulatory intelligence and implement changes• Provide PV advice to clients/colleagues and communicate with agencies as needed• Assist in SOP development and perform assigned tasksQualification• Bachelor’s degree in Life Sciences, Pharmacy, or equivalentExperience• Fresher (Entry-level position)Skills• Strong understanding of pharmacovigilance basics (preferred but not mandatory for freshers)• Proficiency in data entry, medical terminology, and attention to detail• Knowledge of MedDRA coding, causality assessment, and regulatory guidelines (trainable)• Excellent written and verbal communication skills• Ability to work with timelines, maintain records, and ensure compliance• Team player with eagerness to learn and mentor othersAbout the CompanyLambda Therapeutic Research is a leading full-service Global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. Founded in 1998, it provides comprehensive end-to-end clinical research services to innovator, biotech, and generic pharmaceutical industries worldwide. With strategic facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda excels in BA/BE studies, bioanalytical services, clinical trials (Phase I-IV), pharmacovigilance, medical imaging, biostatistics, data management, and more.

Roles & Responsibilities• Execute Medical Affairs plans for pre-launch and newly launched products within assigned therapeutic area• Engage in peer-to-peer scientific exchange with Healthcare Professionals (HCPs), Key External Experts (KEEs), and non-traditional stakeholders (policy makers, PAGs, government bodies)• Provide balanced scientific, clinical, and pharmaco-economic information to support safe and effective product use• Develop and maintain strong professional relationships aligned with the Integrated Engagement Plan• Contribute to and lead components of the Field Medical Strategic Plan (FMSP)• Support and collaborate on evidence generation activities, including ESR/local studies and publications• Organize and facilitate scientific events such as advisory boards, symposiums, MSL meetings, and expert panels• Deliver scientific presentations aligned with field medical communication strategies• Gather and analyze customer insights to inform medical and product strategies• Identify investigators for pre-clinical, clinical, and post-marketing studies• Support investigator-sponsored studies and data generation initiatives• Utilize digital tools and innovative technologies to enhance scientific engagement and patient-centric solutions• Ensure compliance with pharmacovigilance (PV), GxP, GCP, and adverse event reporting requirements• Adhere to Ethical Interaction Policies, internal SOPs, and local regulatory standardsQualification• Master’s degree in a scientific discipline (Essential)• Doctoral degree (MD / PhD / PharmD) preferredExperience• Experience in pharmaceutical industry, clinical research, or regulatory environment preferred• Knowledge of therapeutic area disease management and treatment landscape• Experience in KEE engagement, drug development, or research activities desirableSkills• Strong scientific expertise and analytical thinking• Excellent oral, written, and presentation skills• Strong stakeholder engagement and relationship management• Project management capabilities• Understanding of clinical trials, pharmacovigilance, and regulatory compliance• Ability to communicate effectively through multiple engagement channelsAbout the OrganizationAstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing innovative prescription medicines for serious diseases. The organization is committed to advancing healthcare outcomes through scientific excellence, collaboration, and patient-centric innovation.