Pfizer is inviting applications for the position of Safety Data Management Specialist at its Mumbai, India (Hybrid) office. This is an excellent opportunity for professionals with 2โ4 years of pharmacovigilance (PV) case processing experience who want to build their careers with one of the world’s leading pharmaceutical companies.
The Safety Data Management Specialist will be responsible for reviewing, processing, and managing adverse event reports while ensuring compliance with global pharmacovigilance regulations and Pfizer’s internal safety standards. Candidates with experience in ICSR case processing, narrative writing, MedDRA coding, safety databases, and regulatory reporting are encouraged to apply.
Job Details
| Particular | Details |
|---|---|
| Job Title | Safety Data Management Specialist |
| Company | Pfizer |
| Location | Mumbai, Maharashtra, India |
| Work Mode | Hybrid |
| Job Type | Full-Time |
| Department | Medical / Pharmacovigilance |
| Experience | 2โ4 Years |
| Qualification | B.Pharm or equivalent |
| Salary | โน8 LPA โ โน13 LPA (Estimated) |
Key Responsibilities
The selected candidate will:
- Process Individual Case Safety Reports (ICSRs) accurately and within regulatory timelines.
- Review, validate, and assess adverse event reports.
- Evaluate seriousness, expectedness, validity, and reportability of safety cases.
- Perform case triage and determine appropriate processing workflows.
- Write and edit high-quality medical case narratives.
- Conduct follow-up activities for incomplete safety cases.
- Review processed cases for quality, consistency, and compliance.
- Coordinate with local safety teams and stakeholders for data reconciliation.
- Maintain knowledge of global pharmacovigilance regulations and Pfizer SOPs.
- Support scheduled regulatory reporting activities.
- Participate in internal and external pharmacovigilance initiatives.
Required Qualifications
Candidates should have:
- Bachelor’s degree in Pharmacy (B.Pharm) or equivalent qualification.
- 2โ4 years of pharmacovigilance or safety data management experience.
- Strong experience in ICSR case processing.
- Knowledge of adverse event reporting and pharmacovigilance regulations.
- Experience with safety databases and relational database systems is preferred.
- Medical writing or narrative writing experience is an advantage.
- Excellent English communication skills.
- Good analytical and decision-making abilities.
- Strong computer proficiency.
Preferred Skills
- Pharmacovigilance Case Processing
- Safety Data Management
- Medical Narrative Writing
- Adverse Event Assessment
- Regulatory Reporting
- MedDRA Coding
- Safety Database Management
- Data Reconciliation
- Quality Review
- Global PV Compliance
Why Join Pfizer?
Working at Pfizer offers numerous career benefits, including:
- Opportunity to work with one of the world’s leading pharmaceutical companies.
- Hybrid work model for better work-life balance.
- Exposure to global pharmacovigilance processes.
- Competitive salary and employee benefits.
- Career development through continuous learning.
- Collaborative international work environment.
- Opportunity to contribute to global patient safety.
How to Apply
