Pharmacovigilance Associate

Role Overview We are looking for a skilled Pharmacovigilance Associate to join a leading clinical research organisation in Chennai. In this role, you will be responsible for monitoring the safety of pharmaceutical products throughout their lifecycle by collecting, evaluating, and reporting adverse event data in line with global regulatory standards. You will play a key part in ensuring patient safety and maintaining compliance across both clinical trial and post-marketing surveillance activities. Key Responsibilities - Collect, assess, and process adverse event reports accurately and within regulatory timelines - Manage the safety inbox, acknowledge case receipts, and perform case triage and book-in to the safety database - Enter case details, write medical narratives, and code events, drugs, and medical history using MedDRA and WHO-DD - Apply correct product labelling, perform quality control checks, and finalise case processing - Generate follow-up queries and process literature ICSRs in compliance with monitoring requirements - Collaborate with cross-functional teams to resolve safety-related queries and support ongoing investigations - Stay updated on pharmacovigilance regulations, global safety guidelines, and industry best practices - Support aggregate reporting activities including PSUR and DSUR, and assist in mentoring new team members Required Qualifications - Minimum 2 years of hands-on experience in pharmacovigilance with direct involvement in case processing - Solid background in post-marketing surveillance and or clinical trial case processing - Bachelor's degree in life sciences or a related discipline - Working knowledge of seriousness, expectedness, causality assessment, and global reporting obligations - Familiarity with reconciliation processes, SDEA, and KPI or SLA frameworks - Strong analytical skills with meticulous attention to detail in data handling and reporting - Excellent communication and interpersonal skills for effective cross-team collaboration Why Join Us This is an excellent opportunity to grow your career within a globally respected healthcare intelligence and clinical research organisation that prioritises inclusion, innovation, and employee well-being. The company offers a comprehensive benefits package including health insurance, retirement planning, life assurance, flexible leave entitlements, and access to a global employee assistance programme.

- Minimum 2 years of experience in pharmacovigilance or drug safety case processing - Experience in post-marketing surveillance and clinical trial ICSR processing - Bachelor's degree in life sciences or related field - Proficiency in MedDRA and WHO-DD coding - Knowledge of global pharmacovigilance regulations and safety reporting guidelines - Familiarity with PSUR, DSUR, and aggregate reporting - Understanding of seriousness, expectedness, and causality assessment - Strong analytical and data accuracy skills - Excellent written and verbal communication skills - Ability to work collaboratively in cross-functional teams

- Competitive salary package - Annual leave entitlements - Health insurance coverage for employee and family - Retirement and pension planning options - Life assurance cover - Global Employee Assistance Programme available 24 hours a day - Flexible country-specific optional benefits - Discounted gym memberships and subsidized travel options - Childcare vouchers and bike purchase schemes