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Role & Responsibilities • Perform medical review and clinical assessment of ICSRs in safety databases • Verify adverse event selection, seriousness, MedDRA coding, causality, labeling, narratives and company clinical comments • Handle medical queries, literature screening and safety database follow-ups • Ensure compliance with ICH, EMA, GVP and GCP guidelines • Mentor and train PV associates on safety conventions and event capturing • Support literature surveillance, signal detection and risk management activities • Review and prepare PSURs, PBRERs and Risk Management Plans (RMPs) • Participate in audits, inspections and global pharmacovigilance collaboration Qualifications & Experience • MBBS (PG degree preferred) • Minimum 3 years of Pharmacovigilance / Drug Safety experience Skills • Strong knowledge of global PV regulations (ICH, EMA, GVP, GCP) • Excellent communication and documentation skills • Ability to manage complex safety cases and work in regulated environments • Experience with safety databases and literature surveillance About the Company • Cencora is a global healthcare services organization dedicated to creating healthier futures worldwide. • The company supports pharmaceutical and life sciences organizations with end-to-end drug safety, regulatory, and clinical solutions.

Role & Responsibilities • Perform medical review of Individual Case Safety Reports (ICSRs) for seriousness, causality, labeling and MedDRA coding • Ensure accurate and timely safety case processing in line with global regulatory timelines and client SOPs • Review source documents and narratives for medical accuracy and database consistency • Write company causality comments and route cases through workflows as per SOPs • Validate E2B reporting and perform self-quality checks before case finalization • Lead internal and cross-functional trainings and mentor team members • Handle medical assessment queries, case follow-ups and regulatory clarifications • Support PV compliance, audits, inspections, documentation archiving and process transitions Qualifications & Experience • MBBS / MD • 7–11 years of experience in Pharmacovigilance / Drug Safety medical review Skills • Strong medical writing and safety narrative skills • Expertise in MedDRA, WHO-Drug, ICSR processing and global PV regulations • Proficiency in safety databases and MS Office • Excellent English communication skillsAbout the Company • Accenture is a leading global professional services company specializing in strategy, consulting, digital, technology, and operations.

Roles & Responsibilities: • End-to-end processing of ICSR cases in compliance with global PV regulations • Perform duplicate checks, case validation, data entry, and drug/MedDRA coding • Conduct listedness, causality, and expediting assessments • Prepare high-quality case narratives and ensure timely submissions • Ensure adherence to SOPs, work instructions, and regulatory requirements • Communicate urgent safety issues to Line Manager/QPPV • Maintain accurate documentation and professional communication • Support SOP, WI, template development, and team training • Provide PV guidance to internal teams and clients • Stay updated with regulatory intelligence and implement changes Qualification: • Bachelor’s degree in Pharmacy (B.Pharm), Life Sciences, Biotechnology, Clinical Research, or related discipline Experience: • Freshers eligible • Basic knowledge of Pharmacovigilance, MedDRA, and ICSR lifecycle is an advantage Skills: • Understanding of PV concepts and global safety regulations • Attention to detail and data accuracy • Good written and verbal communication skills • Ability to meet timelines and work in a regulated environment About the Company: Lambda Therapeutic Research Ltd. is a globally recognized Contract Research Organization (CRO) offering comprehensive clinical research and pharmacovigilance services, providing strong career growth opportunities in drug safety and regulatory compliance.How to Apply?Application Link

Role & Responsibilities: • Perform end-to-end Pharmacovigilance case processing activities including case identification, data entry, MedDRA coding, case quality review, submission, follow-up, and case closure for Individual Case Safety Reports (ICSRs) • Review and assess adverse event reports from various data sources such as clinical trials, spontaneous reports, literature, and post-marketing surveillance • Ensure accurate and timely processing of safety cases in compliance with client SOPs, global regulatory requirements (ICH, GxP), and timelines • Perform medical review support activities including seriousness, expectedness, causality assessment, and narrative writing as per guidelines • Ensure data quality, consistency, and completeness in the safety database • Support regulatory submissions to health authorities within defined timelines • Collaborate with internal teams, supervisors, and quality teams to resolve routine issues and discrepancies • Follow established processes, work instructions, and quality standards • Manage individual workload efficiently and meet productivity and compliance targets • Participate in training sessions and process improvement initiatives • Work as an individual contributor within a team environment; role may require rotational shiftsQualification: • Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) from a recognized institutionExperience: • 1-3 years of experience in Pharmacovigilance Operations, Drug Safety, or related Life Sciences roles • Experience in ICSR processing and safety database handling preferredSkills: • Pharmacovigilance Operations • Drug Safety Surveillance • ICSR Case Processing • MedDRA Coding • Adverse Event Reporting • Regulatory Compliance (ICH, GxP) • Safety Database Management • Attention to detail and analytical skills • Good written and verbal communication skills • Ability to follow SOPs and work instructionsAbout the Company: Accenture is a global professional services company with leading capabilities in digital, cloud, and security, combining unmatched experience and specialized skills across more than 40 industries. Accenture provides Strategy and Consulting, Technology and Operations services.

Role & Responsibilities: • Perform triage and initial validity assessment of cases including spontaneous, health authority, clinical trial, and literature cases • Enter and process safety data in pharmacovigilance databases • Conduct initial ICSR assessment, where applicable • Evaluate the need for expedited reporting to health authorities and client partners, ensuring adherence to reporting timelines • Prepare standard safety reporting forms such as CIOMS I, MedWatch forms, and XML files • Prepare and send follow-up requests to obtain missing or additional case information • Submit ICSRs to health authorities and client partners • Complete case documentation in line with project and regulatory requirements • Conduct quality checks on ICSRs to ensure accuracy, completeness, and compliance with industry standards • Perform ICSR search and retrieval from EVWEB database and conduct company vs non-company case assessment • Manage case allocation and workload to meet productivity and quality targets • Provide system and process training to team members • Mentor and support new joiners by guiding them on company processes and fostering a collaborative learning environment • Perform additional responsibilities as assigned by the supervisor in line with process requirements Qualification: • Degree in Pharmacy, Life Sciences, Medicine, or related field Experience: • Relevant experience in Pharmacovigilance / Drug Safety preferred Skills: • ICSR Processing & Case Management • Pharmacovigilance Databases (e.g., EVWEB or similar) • Regulatory Reporting & Compliance • Quality Review & Documentation • Attention to Detail & Analytical Skills • Communication & Team Collaboration About the Company: • Cencora is a global healthcare solutions organization committed to creating healthier futures by improving access to medicines, enhancing patient safety, and supporting pharmaceutical innovation worldwide.

Role & Responsibilities • Perform case intake and processing of Individual Case Safety Reports (ICSRs) • Handle Adverse Event (AE) and Serious Adverse Event (SAE) data • Code medical terms using MedDRA and WHO-DD • Perform quality checks on safety case data • Support global drug safety and compliance activities • Work on post-marketing surveillance and COVID-related safety data • Ensure adherence to ICH-GCP, GVP, and regulatory timelines Qualifications & Experience • B.Pharm, M.Pharm, BSc / MSc Life Sciences • Freshers with internship or project exposure in Pharmacovigilance, Clinical Research, Drug Safety, or COVID safety projects Skills • Basic understanding of pharmacovigilance concepts • Good communication and documentation skills • Willingness to work in rotational shifts About the Company • Accenture supports global pharmaceutical clients through structured pharmacovigilance and drug safety operations, offering corporate exposure and stable career growth

Key ResponsibilitiesReview and evaluate AEs and SAEs; perform first-line clinical assessmentPrepare SAE narratives and collect follow-up safety informationMonitor and report safety data from trials, RWE, spontaneous reports, and literatureSupport DSMB / Safety Review Committee activitiesEnsure timely regulatory safety submissions (FDA, EMA, etc.)Maintain and reconcile safety databasesPerform MedDRA and WHO Drug codingContribute to SaMPs, protocols, SOPs, and CRFsEnsure compliance with GCP, GVP, and global regulationsParticipate in audits and quality improvement initiativesQualificationsBachelor’s degree in Pharmacology, Nursing, Life Sciences, or related field1–2 years experience in Pharmacovigilance / Clinical Safety preferredFreshers considered with relevant internships, projects, or PV certificationsRequired SkillsStrong knowledge of GCP, GVP, and GxP principlesGood clinical judgment and scientific writing skillsHigh attention to detail and strong organizational skillsEffective communication and teamwork in global settingsWhy Emmes GroupGlobal CRO with strong scientific reputationExposure to international trials and regulatory workLearning-focused culture and career growth opportunities

Role & Responsibilities • Assist in processing Adverse Events (AE) and endpoint data, including intake, tracking, and workflow distribution • Track safety case timelines and ensure timely submissions to clients and stakeholders • Support Lifecycle Safety database entry, quality control, and report generation • Coordinate safety report submissions to regulatory authorities and investigators • Maintain project files, case folders, and document control systems • Assist with project start-up activities, system access, and administrative workflows • Archive safety data and manage records post-study closure • Support database validation, user testing, and ad-hoc data searches • Coordinate meetings, courier dispatch, and administrative logistics • Mentor junior administrative staff and support continuous process improvement Qualification • Degree in Life Sciences, Pharmacy, Healthcare, or an allied scientific discipline Experience • Minimum 1 year of relevant experience in pharmacovigilance, clinical research, or safety operations Skills • Good understanding of GCP, ICH guidelines, SOPs, and safety workflows • Working knowledge of medical terminology • Proficiency in Microsoft Office and web-based applications • Strong organizational, multitasking, and time-management skills • Excellent written and verbal communication skills • High attention to detail, accuracy, and compliance About the Company • IQVIA is a globally recognized leader in clinical research, pharmacovigilance, and healthcare intelligence, supporting life sciences companies in the development and commercialization of innovative medical treatments.

Role & Responsibilities • Manage end-to-end ICSR lifecycle, including data entry into pharmacovigilance databases • Book and triage ICSRs, ensuring compliance with PV regulations • Perform medical coding (MedDRA, WHO-DD) and narrative writing for safety reports • Generate follow-up letters to reporters and ensure timely case closure • Review scientific and medical literature to identify valid ICSRs • Perform quality checks (QC) on safety cases to ensure data accuracy and completeness • Assist in the preparation of aggregate safety reports (PSUR, PBRER, DSUR, if applicable) • Support signal detection activities and ADR trend analysis • Ensure compliance with SOPs, project guidelines, and global pharmacovigilance regulations • Stay updated with regulatory changes impacting pharmacovigilance activities • Coordinate with cross-functional teams and affiliates to resolve safety queries Qualification • B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences Experience • 2–5 years of experience in Pharmacovigilance, particularly in ICSR processing, safety data entry, and medical coding Skills • Knowledge of global pharmacovigilance guidelines (ICH, GVP, FDA, EMA) • Proficiency in MedDRA and WHO-DD coding systems • Strong experience in narrative writing and case quality review • Excellent written and verbal communication skills • Ability to perform quality checks and ensure regulatory compliance Why Join Apcer Life Sciences? • Work with a globally recognized pharmacovigilance and regulatory services company • Exposure to international pharmacovigilance projects and a strong focus on career development

Role & Responsibilities • Perform end-to-end pharmacovigilance case processing for clinical trial safety cases • Collect, assess, process, and submit adverse event (AE) and serious adverse event (SAE) reports • Ensure timely and accurate data entry in LSMV (LifeSphere MultiVigilance) database • Maintain compliance with global pharmacovigilance regulations (ICH-GCP, GVP, FDA, EMA) • Support signal detection activities and risk management assessments • Collaborate with cross-functional teams on safety queries and investigations • Stay updated with the latest drug safety guidelines and industry standards Qualification • Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline Experience • Minimum 2+ years of experience in pharmacovigilance case processing • Hands-on experience in Clinical Trial Safety Cases or LSMV/Argus/Safety Databases Skills • Strong analytical skills with high attention to detail • Excellent written and verbal communication skills • Proven commitment to quality, compliance, and patient safety About the Company • ICON plc is a global leader in healthcare intelligence and clinical research, specializing in providing comprehensive clinical development and outsourcing solutions to the pharmaceutical, biotechnology, and medical device industries.

Role & Responsibilities • Manage and execute ICSR regulatory submissions for clinical and post-marketing products • Perform global safety submissions within regulatory timelines • Handle case processing and submissions in ARGUS Safety database • Review AE data and local labeling for accurate scheduling • Monitor submission workflows and resolve pending or failed submissions • Perform major corrections and case distribution • Ensure compliance with global PV regulations, SOPs, WRKs, MANs, and BEDs • Maintain submission tracking and documentation • Identify data gaps and quality issues Qualification • B.Pharm or M.Pharm Experience • 1–4 years in Pharmacovigilance Submission • Experience with ARGUS, ICSR processing, and global regulatory reporting Skills • ARGUS Safety handling • ICSR submissions and distribution • Medical terminology and clinical interpretation • Quality control in PV • Documentation and workflow monitoring • Strong organizational and communication skills About the Company • A leading ITES organization hiring through Outpace Consulting Services • Focused on global pharmacovigilance and regulatory compliance • Provides exposure to international safety submissions and structured compliance processes

Role & Responsibilities • Review and evaluate adverse event reports (AERs) for regulatory reportability • Enter and maintain adverse event data in safety databases • Perform narrative writing and case documentation • Communicate with healthcare professionals to obtain follow-up safety information • Assist in preparation and submission of regulatory safety reports • Monitor safety literature related to company products • Collaborate with clinical research, regulatory affairs and PV teams • Support development and implementation of pharmacovigilance SOPs • Review safety profiles of new and existing products • Participate in risk management plan development and execution • Communicate with regulatory authorities and stakeholders on safety matters Qualification • B.Pharm / M.Pharm / Pharm.D / Life Sciences (preferred) Experience • Fresher / Entry-level candidates can apply Skills • Knowledge of pharmacovigilance and ICSR processing • Narrative writing skills • Basic understanding of regulatory safety reporting • Good communication and documentation skills • Attention to detail and analytical ability About the Company A life sciences organization engaged in pharmacovigilance, clinical research and regulatory safety operations, ensuring patient safety and regulatory compliance across products.

Role & Responsibilities Manage processing, follow-up, analysis and regulatory reporting of AEs and SAEs for marketed and investigational human and veterinary products Perform medical evaluation of safety cases in compliance with global regulatory requirements Prepare aggregate safety reports including PBRERs, PSURs, Addendum PSURs, ACOs, PADERs and PSUR line listings Perform quality checks of aggregate safety reports Conduct signal detection related analyses including cumulative and issue-based event analyses Ensure compliance with client conventions, SOPs and global pharmacovigilance guidelines Maintain accuracy, consistency and timelines for all safety deliverables Qualification Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics) BDS / B.V.Sc. / M.V.Sc. Experience Pharmacovigilance industry experience preferred Skills Strong knowledge of medical terminology and pharmacovigilance processes Excellent written and spoken English communication skills Ability to prepare concise and accurate medical synopses and narratives Ability to evaluate safety data independently and draw conclusions Proficiency in MS Word, Excel, PowerPoint and web-based safety applications Strong analytical and documentation skills About the Company Continuum is a leading contract research organization providing services in Pharmacovigilance, Regulatory, Evidence Evaluation and Technology The organization employs scientists and physicians to support global safety and regulatory operations

Key Responsibilities • Oversee adherence to Quality Management Framework procedures to ensure delivery of high-quality pharmacovigilance cases • Review and improve project Quality Management Systems and suggest process enhancements • Collaborate with Team Leads, Trainers and Medical Reviewers to implement new or enhanced quality processes • Coordinate with Quality Reviewers to maintain compliance with quality standards • Review late logs, perform Root Cause Analysis (RCA) and define Corrective and Preventive Actions (CAPA) • Ensure timely documentation and closure of late logs as per client SOPs • Conduct training, refresher sessions and awareness programs on case processing conventions • Work with Operational Excellence and Capability Development teams to enhance engagement quality • Support audits, inspections, SOP development and maintenance • Review safety case data for completeness and accuracy • Track, submit and distribute quality and compliance reports • Maintain client mailboxes, SharePoint, databases and safety tools • Drive zero quality deviations leading to regulatory submission delays • Support transitions, documentation archiving, and cross-functional coordination Skills & Competencies • Working knowledge of ICH, GCP, FDA, MHRA and global PV regulations • Strong attention to detail and data accuracy • Good understanding of medical terminology • Strong verbal and written communication skills • Proficiency in MS Excel, Word and PowerPoint • Strong interpersonal and stakeholder management skillsAbout Accenture Accenture is a global professional services company delivering Strategy & Consulting, Technology and Operations services across more than 120 countries. With industry-leading capabilities in digital, cloud and security, Accenture supports global life sciences clients through advanced technology and intelligent operations centers.

Role & Responsibilities • Perform medical review of company, literature, and regulatory ICSRs • Select and assess adverse events for seriousness and expectedness • Conduct MedDRA coding review of adverse events • Review causality assessments and perform label assessment • Classify product role (suspect, concomitant, interacting) • Review medical history, concomitant conditions, and laboratory data • Evaluate case narratives for medical accuracy and completeness • Perform medical review and quality review of aggregate safety reports (PSURs, PADERs) • Conduct medical review of Risk Management Plans (RMPs) • Review Signal Management Reports and support signal evaluation Qualification • MBBS or MD (Pharmacology preferred) Experience • Relevant experience in pharmacovigilance medical review or drug safety preferred Skills • Strong knowledge of pharmacovigilance regulations and safety reporting standards • MedDRA coding proficiency • High attention to clinical detail and document quality • Strong written and verbal communication skills • Ability to work with global safety documentation and regulatory timelines About the Company The hiring organization operates in regulated pharmacovigilance and drug safety domains, supporting global pharmaceutical safety surveillance, aggregate reporting, and risk management activities aligned with international regulatory standards.

Role & Responsibilities • Oversee pharmacovigilance vendors and CRO partners in a sponsor environment • Review, manage and approve SAEs, SUSARs and ICSR submissions • Support preparation and medical review of DSURs and aggregate safety reports • Provide safety input into clinical protocols, Investigator’s Brochures and trial documents • Coordinate with Clinical Operations, QA and Regulatory Affairs teams • Support inspection readiness, audits and safety governance meetings • Manage long-term follow-up and safety activities specific to Cell & Gene Therapy trials • Ensure compliance with ICH-GCP, ICH E2 and global PV regulations Qualification • Degree in Pharmacy, Life Sciences or related discipline Experience • Experience in Pharmacovigilance and Clinical Trials • Prior exposure to sponsor oversight or CRO/vendor management preferred Skills • Strong understanding of clinical safety reporting and PV regulations • Ability to work in cross-functional sponsor teams • Good documentation, coordination and communication skills • Exposure to Cell & Gene Therapy, Oncology or Rare Disease programs preferred About the Company This is a growing sponsor organization focused on developing innovative Cell & Gene Therapy programs, driving advanced clinical research with strong regulatory compliance and patient safety governance at its core.

Role & Responsibilities • Perform medical review and approval of post-marketing ICSRs and clinical trial SAE reports • Assess seriousness, expectedness, causality and coding accuracy of safety cases • Prepare company medical comments, follow-up queries and similar event analysis • Complete and maintain safety trackers and supporting documentation • Support the Qualified Person for Pharmacovigilance in evaluation of safety issues • Review and provide medical input into periodic safety reports • Review literature screening strategies and evaluate articles for safety case identification • Contribute to medical evaluation of safety signals and ongoing risk assessment Qualification • MD (Doctor of Medicine) Experience • Open to Medical Doctors seeking entry or early-career growth in pharmacovigilance Skills • Strong understanding of pharmacovigilance principles and safety reporting • Ability to plan, organize, prioritize and manage multiple safety tasks • Excellent written and verbal English communication (minimum B2 level) • Strong presentation and documentation skills • Advanced proficiency in MS Office tools • Ability to work effectively across cultures and cross-functional teams About the Company PrimeVigilance is a global pharmacovigilance and regulatory affairs organization with operational presence across North America, Europe and Asia, supporting pharmaceutical and biotech companies with end-to-end drug safety, medical information and risk management services.

Role & Responsibilities Perform end-to-end ICSR processing for AE, SAE and SUSAR cases Identify, triage and create cases in global safety databases Review source documents for validity and medical relevance Perform MedDRA and WHO-Drug coding Draft case narratives and E2B sender comments Manage follow-ups, reconciliations and regulatory timelines Support audits, inspections and pharmacovigilance projects Handle literature intake, mailbox monitoring and translations Qualification B.Pharm BSc Nursing Bachelor’s Degree in Life Sciences Experience 0–1 year (Freshers eligible) Skills Basic knowledge of pharmacovigilance and ICSR workflows Familiarity with MedDRA and WHO-Drug Good documentation and MS Office skills Strong English communication skills Ability to work in compliance-driven environmentsAbout the Company Accenture is a global professional services leader operating in over 120 countries Delivers technology-driven healthcare and life sciences solutions Provides structured career growth and global exposure in pharmacovigilance

Role & Responsibilities Perform end-to-end ICSR case processing Triage, prioritize and assess adverse event cases Conduct MedDRA and WHO-Drug coding Assess seriousness, causality and expectedness Draft narratives and sender comments Manage follow-ups, reconciliations and regulatory timelines Support inspections, audits and safety surveillance activities Handle literature review and mailbox management Qualification Bachelor of Ayurvedic Medicine and Surgery (BAMS) Bachelor’s Degree in Life Sciences Master’s Degree in Life Sciences Experience 1–3 years of pharmacovigilance experience Skills Strong knowledge of pharmacovigilance workflows Good command over MedDRA and WHO-Drug coding Medical writing and documentation skills Proficiency in MS Office tools Excellent communication and compliance orientationAbout the Company Accenture is a global professional services organization with large-scale life sciences operations Works with international clients and regulatory frameworks Offers long-term growth in drug safety and pharmacovigilance careers