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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.

About Role & Responsibilities • Lead delivery operations for pharmacovigilance and drug safety services • Ensure adherence to global pharmacovigilance standards and timelines • Collaborate with teams to manage client relationships and regulatory compliance Qualification • B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences Experience • 3+ years in pharmacovigilance or related operations roles Skills • Leadership and team management skills • In-depth knowledge of pharmacovigilance processes and regulations About the Company Arcolab is a leader in pharmacovigilance and drug safety services, offering comprehensive solutions to the pharmaceutical industry

Roles & Responsibilities• Perform medical information contact center (MICC) activities and case intake• Process adverse event (AE) and adverse drug reaction (ADR) reports• Ensure timely, accurate, and compliant safety data entry• Follow global pharmacovigilance regulations and internal SOPs• Support safety surveillance and regulatory reporting activities• Maintain proper documentation and quality standardsQualification• B.Pharm / M.Pharm / BDSExperience• Freshers and experienced candidates can applySkills• Basic knowledge of pharmacovigilance or clinical research• Good communication and documentation skills• Understanding of GCP, ICH guidelines, and drug safety concepts• Willingness to learn and adapt in a regulated work environment• Attention to detail and quality-oriented approachAbout the OrganisationPharmazone is a growing organization in the pharmaceutical and clinical research domain, offering opportunities in clinical research and pharmacovigilance. The company provides structured learning, hands-on exposure, and clear career growth paths for freshers and experienced professionals in the life sciences industry.

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 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

Roles & Responsibilities: • Perform daily website review and pharmacovigilance compliance monitoring for Europe, UK, WHO, and ROW markets (India, Kazakhstan, South Africa, Ukraine, etc.). • Identify safety-related updates and share with relevant stakeholders: ICSR updates with Case Processing team, PSUR updates with PSUR team, and signal-related updates with Signal Management team. • Draft, review, and update SOPs in line with evolving global pharmacovigilance regulations. • Coordinate with QPPV and Local Responsible Persons (LRPs) for regulatory queries and training activities. • Archive emails and documents as per pharmacovigilance compliance requirements. • Collect safety data from cross-functional teams for compliance report preparation. • Prepare, review, and circulate compliance reports as per approved templates and SOPs. • Conduct and support compliance meetings with QPPV, draft Minutes of Meeting (MoM), and track action items. Qualification: • M.Pharm in Pharmacology or Pharmaceutics. Experience: • 1–2 years of hands-on experience in Pharmacovigilance compliance, website review, and global regulatory reporting. Skills: • Strong knowledge of GVP Modules and global PV regulations (EU, UK, USFDA, India, MHRA, ROW). • Hands-on understanding of PSMF, ICSR, PSUR, and RMP. • Excellent written and verbal communication skills. • Strong documentation, time management, and coordination abilities. • Ability to work effectively in cross-functional pharmacovigilance teams. About the Organization: Macleods Pharmaceutical Ltd is a leading Indian pharmaceutical company with a strong global presence and a robust R&D focus. Known for its commitment to quality, compliance, and patient safety, Macleods operates across multiple regulated markets and offers professionals an opportunity to work on global pharmacovigilance systems in a dynamic and growth-oriented environment.

Role & Responsibilities • Draft and revise Pharmacovigilance Agreements (PVAs) ensuring alignment with company requirements • Review PVAs for quality and consistency with global and local regulatory standards • Address comments from company and collaborating partners on PVAs • Manage dedicated PVA mailbox and respond to queries • Announce new or revised PVAs to all relevant client stakeholders • Maintain PVA tracker for all active global PVAs, including reconciliations and updates • Perform compliance monitoring of PVAs and prepare dashboards for management review • Assist Project Manager in managing project-related documents and trackers • Upload and maintain PVAs and associated documentation in company repository • Attend team meetings to provide status updates and report any issues with PVAs Qualification • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field • Strong knowledge of global pharmacovigilance regulations (ICH, GVP)Experience • Minimum 2–3 years of experience in pharmacovigilance • Hands-on experience with global and local PVAs and contractual pharmacovigilanceSkills • Expertise in drafting, reviewing, and maintaining PVAs • Knowledge of global pharmacovigilance standards and compliance monitoring • Excellent written and verbal communication skills • Strong organizational and document management skills • Attention to detail and ability to manage multiple tasks concurrentlyAbout Company • Tata Consultancy Services (TCS) is a leading global IT and consulting services organization , Provides solutions across Life Sciences, Healthcare, and technology domains

Roles & Responsibilities • Ensure compliance with global pharmacovigilance regulations (EMA, EU GVP, ICH E2A/E2B, FDA, local guidelines) • Maintain and update pharmacovigilance documentation including SOPs and PV Master File (PSMF) • Assist during regulatory inspections, audits, and CAPA implementation • Support preparation, review, and submission of safety documents:  ICSRs, PSURs / PBRERs, DSURs, Risk Management Plans (RMPs) • Submit safety reports to EudraVigilance and other global safety databases • Perform literature screening and safety data evaluation • Assist in signal detection, risk minimization activities, and safety review meetings • Support preparation of SmPC, PIL, and package leaflets • Code and review adverse events using MedDRA and WHO-DD • Maintain accurate safety databases, trackers, and compliance logs • Complete mandatory PV trainings and stay updated with evolving regulations Qualification • B.PharmExperience • 0–1 year of experience in Pharmacovigilance • Freshers with PV training are eligible Skills • Basic understanding of pharmacovigilance regulations (EMA, EU GVP, ICH, FDA) • Knowledge of ICSR processing and safety reporting • Familiarity with MedDRA and WHO-DD coding • Strong attention to detail and documentation accuracy • Good written and verbal communication skills • Compliance-oriented and proactive learning mindset About the Organisation Lincoln Pharmaceuticals is a well-established Indian pharmaceutical company with a strong presence in domestic and international markets. The company is committed to quality, patient safety, and regulatory excellence, offering strong career growth opportunities in pharmacovigilance, regulatory affairs, and drug safety operations.

Roles & Responsibilities• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports• Perform case processing and data entry in safety databases such as Argus, ARISg, Oracle, or similar systems• Conduct literature searches and review scientific publications for safety-related information• Assist in signal detection, risk assessment, and safety trend analysis• Ensure compliance with ICH-GCP, ICH-E2B, and applicable regulatory guidelines• Support preparation and review of PSURs, PBRERs, and other regulatory safety documents• Maintain accurate, complete, and audit-ready pharmacovigilance documentation• Coordinate with Clinical, Regulatory, Quality, and other cross-functional teams• Follow SOPs, timelines, and quality standards for safety reportingQualification• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplineExperience• Freshers are eligible to apply• Internship or academic exposure to pharmacovigilance or clinical research is an advantageSkills• Basic understanding of pharmacovigilance concepts and safety reporting• Knowledge of ICH-GCP and global drug safety regulations• Strong attention to detail and documentation skills• Good written and verbal communication skills• Ability to work in a team-oriented and compliance-driven environment• Willingness to learn safety databases and PV workflowsAbout the OrganisationThe organization is a growing healthcare and life sciences company focused on ensuring patient safety and regulatory compliance through high-quality pharmacovigilance and drug safety services, offering strong learning and career development opportunities for fresh graduates.

Role & Responsibilities • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. • Review includes coding, assessment of seriousness, expectedness, and causality. • Write Company comments, follow-up questions, and analyze similar events. • Complete all required supporting documentation, such as trackers. • Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues. • Review and provide input in periodic reports. • Review literature screening search strategies and review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings. Qualification • MD qualification is required. Experience • Proven ability to plan, organize, prioritize, and execute multiple tasks efficiently. Skills • Ability to work cross-culturally and cross-functionally, valuing teamwork. • Strong communication and presentation skills. • Advanced English skills, both verbal and written (at least B2 level). • Advanced knowledge of MS Office. About The Company • PrimeVigilance offers an opportunity for Medical Doctors to develop a career in Drug Safety.The company’s Pharmacovigilance Physician team operates across North America, Europe, and Asia, providing global pharmacovigilance services. PrimeVigilance is focused on creating a collaborative, high-quality environment for physicians interested in pharmacovigilance.

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.

Roles & Responsibilities • Support project monitoring and coordination using project management tools • Prepare study safety documents including SAE reporting forms and guidelines • Develop training materials for investigator meetings and safety trainings • Generate progress reports, listings, and study-related outputs for PVSM and clients • Assist in SAE and ICSR processing as per protocols, SOPs, and regulatory guidelines • Maintain and update internal safety databases • Follow up with investigator sites for query resolution • Prepare high-quality case narratives for safety reporting • Distribute ICSRs to Ethics Committees, Investigators, and MAHs • Prepare and circulate 6-monthly SUSAR line listings • Support preparation and submission of DSURs to Competent Authorities and Ethics Committees • Assist with MedDRA coding in coordination with Data Management and Statistics teams • Support additional pharmacovigilance activities as per departmental requirements Qualification • Degree in Pharmacy, Life Sciences, or related discipline Experience • Relevant experience in Pharmacovigilance, Clinical Research, or Safety Operations Skills • Pharmacovigilance processes and SAE / ICSR reporting • Safety database handling and case processing • MedDRA coding knowledge • ICH, EMA, and FDA regulatory guidelines • Microsoft Office and database management tools • Strong documentation, coordination, and communication skills About the Organisation Veeda Clinical Research is a leading global CRO providing comprehensive clinical research, bioanalytical, and pharmacovigilance services. The organization is known for its regulatory expertise, quality-driven processes, and strong presence in domestic and international clinical research.

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

Role & Responsibilities• Perform ICSR case processing and safety data entry in Argus Safety Database within defined timelines• Download, triage, upload, and book-in regulatory and EMA MLM safety reports• Manage literature screening, case triaging, and safety data archiving• Ensure accurate MedDRA coding for all reported adverse events• Follow pharmacovigilance SOPs, processes, and global guidelines strictly• Communicate safety data requirements with internal and external stakeholders• Maintain compliance with global pharmacovigilance legislation and reporting timelines• Support aggregate reporting and signal management activitiesQualification• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplinesExperience• 1–3 years of experience in Pharmacovigilance or Drug Safety• Hands-on experience with ICSR processing and Argus Safety Database preferredSkills• Strong knowledge of ICSR workflows, MedDRA coding, and regulatory reporting• Good understanding of GVP guidelines and global PV regulations• High attention to detail and quality-focused approach• Excellent written and verbal communication skills• Ability to manage multiple tasks and meet strict timelinesAbout the Company• Jubilant Pharma Limited is a global integrated pharmaceutical organisation, Operates USFDA-approved manufacturing and research facilities, Engaged in pharmaceuticals, generics, and drug safety operations.

About Role & Responsibilities • Perform pharmacovigilance activities such as signal detection and risk management • Ensure compliance with regulatory requirements for drug safety • Assist in preparing safety reports and presenting findings Qualification • B.Pharm Experience • 0-2 years in pharmacovigilance Skills • Strong understanding of pharmacovigilance processes • Good communication and report writing skills About the Company Cosette Pharma specializes in the development and commercialization of pharmaceutical products

Roles & Responsibilities• Lead safety case processing and support global safety evaluation activities• Monitor compliance with PVASC requirements for GSK and third parties including HSI reconciliation• Perform quality checks of adverse event reports in global safety databases and escalate issues• Maintain pharmacovigilance databases, EDMS, PVASC platforms, and shared systems• Collect, analyze, and document safety data from local operating companies• Generate standard safety listings and manage document archiving processes• Support regulatory inspections and internal audits under senior guidance• Contribute to SOPs, guidance documents, and process improvement initiatives• Collaborate with internal and external stakeholders with minimal supervisionQualification• Bachelor’s degree in life sciences, pharmacy, medicine, nursing, or related health scienceExperience• 5–9 years of pharmacovigilance or drug safety experience including ICSR processingSkills• Strong knowledge of pharmacovigilance regulations, GVP, and clinical safety documentation• Experience with safety databases and electronic case processing systems• Good understanding of medical terminology and MedDRA coding• Proficiency in MS Word, Excel, PowerPoint, SharePoint, and PowerBI• Strong organizational, analytical, and stakeholder management skillsAbout the CompanyGlaxoSmithKline (GSK) is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. GSK focuses on vaccines and specialty medicines to positively impact billions of patients worldwide while fostering a culture driven by integrity, innovation, and patient safety.

Role & Responsibilities • Manage aggregate safety reporting and benefit-risk assessments • Lead pharmacovigilance projects and submissions to regulatory authorities • Coordinate with global safety stakeholders to ensure timely reporting and compliance • Ensure inspection readiness and adherence to regulatory requirements Qualification • MBBS / MD Experience • Strong experience in aggregate reporting and pharmacovigilance project management Skills • Excellent knowledge of safety data review and submission processes • Proficient in managing pharmacovigilance teams and regulatory interactions • Strong organizational and leadership abilitiesAbout the Company • Sun Pharmaceutical Industries Ltd. is one of India’s largest global pharmaceutical companies. • It is a leader in the manufacturing of specialty and generic medications, with a focus on drug safety, regulatory compliance, and patient health.

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

Roles & 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 current drug safety guidelines and industry standards Qualification: • Bachelor’s degree in Life Sciences, Pharmacy, or 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 Organisation: ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing patient safety and delivering high-quality clinical development solutions across the pharmaceutical and biotech industries.

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.