Looking to build a career in pharmacovigilance and drug safety? Here’s an excellent opportunity for life sciences graduates. Fortrea is hiring for the position of Safety Science Coordinator I in Pune. This role is ideal for candidates seeking entry-level pharmacovigilance jobs in India, especially those interested in adverse event processing, safety database management, and regulatory submissions.
This position involves supporting Clinical Safety and Post-Marketing Surveillance (PSS) operations, including processing Adverse Events (AE) and Serious Adverse Events (SAE) in compliance with global regulatory standards.
About the Company – Fortrea
Fortrea is a global Contract Research Organization (CRO) specializing in clinical development, safety, and regulatory solutions. The company supports pharmaceutical, biotechnology, and medical device companies worldwide.
Job Details
- Job Title: Safety Science Coordinator I
- Location: Pune, Maharashtra
- Job Type: Full-time
- Department: Clinical Safety / Pharmacovigilance
Key Responsibilities
This Safety Science Coordinator I job in Pune involves:
Pharmacovigilance & Safety Processing
- Processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
- Logging AE/SAE cases in safety databases
- Writing patient narratives
- Coding adverse events using MedDRA
- Performing listedness assessment (for marketed products)
- Submitting expedited SAE reports within regulatory timelines
Regulatory & Compliance
- Supporting regulatory submissions to authorities and ethics committees
- Maintaining adverse event tracking systems
- Assisting in database reconciliation
- Ensuring compliance with SOPs and Quality Management Systems
Documentation & Coordination
- Maintaining safety study files
- Supporting safety data archiving
- Coordinating meetings and project documentation
- Training and mentoring junior PSS assistants
This role is ideal for candidates seeking drug safety associate jobs, clinical safety coordinator roles, or pharmacovigilance fresher jobs in Pune.
Eligibility Criteria
Fortrea considers candidates with:
Educational Qualification
Degree preferred in:
- Pharmacy (B.Pharm, M.Pharm, PharmD)
- Life Sciences
- Biological Sciences
- Nursing
- Medical Sciences
Experience Requirements
- 0–2 years of pharmacovigilance or safety experience, OR
- Relevant experience in:
- Clinical Data Management
- Regulatory Affairs
- Medical Affairs
- CRO Industry
- Quality Assurance
PharmD candidates with residency/fellowship may be considered as experienced.
Required Skills
- Strong attention to detail
- Good written and verbal communication
- Knowledge of AE/SAE processing
- MedDRA coding knowledge
- MS Office proficiency
- Ability to manage multiple tasks
- Team collaboration skills
Why This Role Is Important for Freshers
This is a strong entry-level opportunity in:
- Pharmacovigilance career path
- Drug safety operations
- Clinical research organization jobs
- Regulatory safety reporting
Candidates looking for Pune pharmacovigilance jobs for freshers will find this position highly relevant.
Salary (Estimated)
Based on industry benchmarks for entry-level pharmacovigilance roles in Pune:
₹3,50,000 – ₹5,50,000 per annum (CTC)
(Final compensation depends on qualifications and experience.)
Work Environment
- Office-based in Pune or hybrid/remote (as applicable)
- Compliant with international safety and health regulations
How to Apply
