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Company: Fortrea
Position: Safety Science Analyst
Location: Pune, India
Job Type: Full-time
Job Requisition ID: 254430
Application Deadline: August 25, 2025
Job Overview
Fortrea is looking for Safety Science Analysts to support its Clinical Safety and PSS operations. The role involves managing the adverse events (AEs) process from both clinical trials and post-marketing settings, ensuring compliance with regulatory requirements and providing high-quality service to clients.
The analyst will handle expedited case processing, reporting to regulatory authorities, and maintaining compliance with safety standards. This role is vital in ensuring patient safety and regulatory adherence in all safety reporting activities.
Key Responsibilities
- Perform case intake and triage of safety information from clinical trials or spontaneous reports.
- Enter adverse event data into tracking systems.
- Write patient narratives and code adverse events using MedDRA.
- Conduct listedness assessments for marketed products.
- Generate queries and collect missing information in collaboration with medical staff.
- Submit expedited SAE reports to regulatory authorities, ethics committees, investigators, and clients within strict timelines.
- Support the preparation and submission of periodic safety reports to global agencies.
- Assist in reconciliation of safety databases.
- Work within SOPs, Work Instructions, and Quality Management Systems.
- Maintain supporting documentation for adverse event reporting requirements.
- Support compliance with regulatory frameworks and internal quality standards.
- Build strong relationships across functional safety units.
Qualifications
- Education:
- Non-degree candidates with 6 months – 1 year safety experience.
- Associate Degree with 0–6 months safety/relevant experience.
- BS/BA, MS/MA, or PharmD with 0–6 months safety/relevant experience.
- Relevant fields: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
- Relevant/Equivalent Experience: Medical Affairs, Clinical Data Entry, Clinical Data Management, Monitoring, Regulatory Affairs, or Quality Assurance.
Skills & Experience Required
- Strong attention to detail.
- Excellent written and verbal communication skills.
- Team player with problem-solving mindset.
- Proficiency in MS Office applications.
- Ability to work with numerical data and proof-reading accuracy.
- Prior safety database or regulatory submission experience (preferred).
Why Join Fortrea?
Fortrea is a global clinical research organization that values innovation, compliance, and patient safety. Joining the team provides an excellent opportunity to build a career in pharmacovigilance and drug safety operations, working with international clients and regulatory bodies.
📅 Apply before: August 25, 2025
📍 Location: Pune, India
🔗 Apply Online: Fortrea Careers
