Pfizer is a leading global biopharmaceutical company committed to discovering, developing, and providing innovative healthcare solutions. Our Worldwide Medical and Safety team plays a crucial role in ensuring evidence-based medical decisions, improving patient health outcomes, and maintaining the highest safety standards for medicines worldwide.
At Pfizer, we believe in using your power for purpose—whether it’s ensuring scientific accuracy, addressing data gaps, or collaborating with healthcare stakeholders to promote the safe use of medicines.
Job Description: Associate – Safety Data Management Specialist
Primary Responsibilities
As an Associate – Safety Data Management Specialist, you will be responsible for:
- Case Processing Activities:
- Reviewing, ranking, verifying, and documenting case-related information (event terms, validity, seriousness, timelines).
- Ensuring accuracy and consistency in case processing.
- Writing and editing case narratives.
- Determining and executing appropriate case follow-ups, including generating follow-up requests.
- Compliance & Quality Checks:
- Reviewing processed cases for accuracy, consistency, and compliance with regulatory standards.
- Identifying complex cases and escalating them as needed.
- Regulatory & Safety Expertise:
- Staying updated on global safety regulations, SOPs, and data entry conventions.
- Determining reportability of scheduled reports in line with regulatory requirements.
- Collaboration:
- Liaising with internal and external stakeholders for safety data collection and reconciliation.
- Participating in safety-related activities as required.
Eligibility Criteria (Minimum Requirements)
- Education: B.Pharm, M.Pharm, or Pharm.D only.
- Experience: 1-2 years in end-to-end ICSR (Individual Case Safety Report) processing, including listedness assessment.
- Skills:
- Ability to work in a team environment.
- Strong attention to detail.
Preferred Qualifications (Bonus Points If You Have)
- Hands-on experience with ARGUS safety database.
- Proficiency in processing E2B R2 and R3 (XML format) source documents.
- Good understanding of medical terminology and global drug safety regulations.
Work Location & Assignment
- Hybrid work model (combination of in-office and remote work).
- Location: Chennai, India.
Location: Chennai, India
Job Type: Full-time
Posted: Today
Requisition ID: 4939465
Why Join Pfizer?
- Global Impact: Contribute to life-saving medical advancements.
- Career Growth: Opportunities for professional development in pharmacovigilance and drug safety.
- Inclusive Culture: Pfizer is an equal opportunity employer, fostering diversity and inclusion.
How to Apply
Interested candidates can apply through Pfizer’s official career portal using Requisition ID: 4939465.
