Fortrea, a global leader in clinical research and patient safety, is hiring a Safety Science Coordinator I in Pune. This is a fantastic opportunity for freshers and early-career professionals in pharmacovigilance, drug safety, and life sciences to step into the growing field of clinical safety and regulatory compliance.
If you are detail-oriented, passionate about healthcare, and eager to work on adverse event reporting, safety databases, and regulatory submissions, this role could be your perfect fit.
📝 Job Responsibilities
As a Safety Science Coordinator I, your core responsibilities include:
- Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project files.
- Log and process Adverse Events (AEs) / Serious Adverse Events (SAEs).
- Write patient narratives and code events using MedDRA.
- Generate queries for missing or discrepant safety data.
- Submit reports to clients, regulatory authorities, ethics committees, and investigators.
- Support peer/quality review of processed reports.
- Train and mentor new safety staff.
- Ensure compliance with SOPs, WIs, and Quality Management Systems.
- Provide administrative and coordination support for clinical safety operations.
🎓 Qualifications
Applicants should meet one of the following:
- Non-Degree with 1–2 years of safety experience.
- Associate Degree with 6 months – 1 year of safety or relevant experience.
- B.Sc./B.Pharm with 0–1 year of experience in pharmacovigilance or related fields.
- M.Sc./M.Pharm with up to 6 months of relevant experience.
- PharmD (freshers or residency/fellowship).
Relevant degrees: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences.
Relevant experience includes: Pharmacovigilance, Clinical Data Management, Medical Affairs, Regulatory Affairs, or Quality Assurance.
🌟 Key Skills
- Strong communication (English & local language).
- Attention to detail & logical thinking.
- Good MS Office and database management skills.
- Team player with multitasking ability.
💼 Benefits of Joining Fortrea
- Opportunity to grow in pharmacovigilance and drug safety.
- Exposure to global clinical research standards.
- Work in a supportive and collaborative team environment.
- Training and mentoring opportunities.
- Hybrid/office-based role in Pune.
📌 How to Apply
