Job Summary
Pfizer is seeking a detail-oriented and motivated Associate – Safety Data Management Specialist to join our team in Chennai, India. In this hybrid role, you will be instrumental in ensuring the accuracy and regulatory compliance of our global pharmacovigilance data. This position is ideal for pharmacy graduates looking to build a career within a leading global biopharmaceutical company that prioritizes innovation, patient safety, and professional development.
About Pfizer
Pfizer is a global leader in the biopharmaceutical industry, dedicated to discovering and developing breakthrough therapies that improve patients’ lives. Our work spans critical areas, including vaccines, oncology, internal medicine, and rare diseases. We pride ourselves on cultivating a diverse, inclusive, and high-performing workplace that empowers every colleague to reach their full potential through continuous learning and professional growth.
Responsibilities
As a Safety Data Management Specialist, your core responsibilities will include:
- Case Processing: Process and review Individual Case Safety Reports (ICSRs) with a high degree of accuracy and strict adherence to internal and regulatory standards.
- Data Assessment: Evaluate case validity, determine the seriousness of reported events, and assess regulatory reportability requirements.
- Narrative Writing: Draft and edit clear, concise, and consistent case narratives that accurately reflect clinical data.
- Follow-up Management: Actively perform follow-ups on safety cases, including the generation and tracking of queries to ensure complete data.
- Global Collaboration: Partner with cross-functional global teams to ensure effective data reconciliation and information exchange.
- Regulatory Compliance: Stay current with global pharmacovigilance regulations and internal Standard Operating Procedures (SOPs) to ensure operational excellence.
- Audit Support: Provide documentation and support during internal audits and regulatory inspections to ensure compliance integrity.
Requirements
To be successful in this role, candidates must meet the following criteria:
- Education: Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or Pharm.D is mandatory.
- Experience: 0–2 years of relevant experience in end-to-end ICSR processing, including demonstrated experience with listedness assessments.
- Technical Skills:
- Strong working knowledge of medical terminology.
- Solid understanding of global regulatory requirements in pharmacovigilance.
- Preferred Qualifications:
- Practical experience working with the ARGUS safety database.
- Familiarity with E2B R2/R3 (XML) case processing standards.
Benefits
Joining Pfizer offers you more than just a job; it provides a platform for a successful career. We offer:
- Hybrid Work Model: A flexible arrangement that balances office collaboration with remote work.
- Competitive Compensation: A market-leading salary package supplemented by performance bonuses and comprehensive health insurance.
- Professional Growth: Access to global exposure in the pharmacovigilance sector and structured opportunities for learning and development.
- Inclusive Culture: A supportive, diverse, and inclusive work environment where every voice is heard and valued.
How to Apply
If you are passionate about patient safety and eager to contribute to a world-class team, we encourage you to apply. Please visit the official Pfizer careers portal using the link below to submit your application and view further details:
Click Here to Apply for the Associate – Safety Data Management Specialist Position
Pfizer is an equal opportunity employer and values diversity at our company.