Pfizer is a global leader in biopharmaceuticals, committed to delivering breakthroughs that change patients’ lives. With a strong presence in Chennai, India, Pfizer offers dynamic career opportunities in pharmacovigilance, regulatory reporting, and drug safety.
Join a team that values innovation, compliance, and patient safety while working on critical post-marketing safety reports for global regulatory submissions.
Detailed Job Description
Position: Aggregate Report Analyst (Senior Associate & Manager)
Location: Chennai, India
Job Type: Full-time
Posted: Recently
Key Responsibilities:
✔ Develop regulatory documents like DSURs, PBRERs, Risk Management Plans (RMPs), and Periodic Safety Reports
✔ Ensure compliance with global pharmacovigilance regulations (FDA, EMA, etc.)
✔ Collaborate with cross-functional teams (safety, regulatory, clinical)
✔ Review and analyze safety data for benefit-risk assessments
✔ Oversee external vendors & contractors for document preparation
✔ Drive process improvements in safety reporting
Eligibility Criteria:
For Senior Associate:
- Bachelor’s degree in Life Sciences + 2+ years in pharma/clinical/safety/regulatory roles
- Preferred: MD, PharmD, or Master’s/PhD in a relevant field
- Strong medical writing & data analysis skills
For Manager:
- Bachelor’s degree + 3+ years in pharmacovigilance/regulatory reporting
- Advanced degree (MD, PharmD, PhD) preferred
- Experience in leading teams & vendor oversight
Skills Required:
- Knowledge of ICH-GCP, GVP, and regulatory guidelines
- Ability to interpret safety data & write regulatory reports
- Strong communication & project management skills
Benefits of Working at Pfizer Chennai
✅ Competitive salary & performance bonuses
✅ Health & wellness programs
✅ Career growth in global pharmacovigilance
✅ Flexible work policies
✅ Learning & development opportunities
How to Apply
Application Link For Aggregate Report Analyst
Application Link For Aggregate Report Analyst Manager
