Fortrea is seeking a Safety Science Analyst to join our Clinical Safety and Pharmacovigilance (PSS) team in Pune. This hybrid role involves managing adverse event (AE) reports from clinical trials and post-marketing surveillance, ensuring compliance with global regulatory standards. If you have a background in life sciences, pharmacy, or medicine and are looking for an entry-level role in drug safety, this could be the perfect opportunity for you!
Key Responsibilities:
✔ Perform case intake and triage of safety reports from clinical trials and post-marketing sources.
✔ Assist in data entry, coding (MedDRA), and narrative writing for adverse event cases.
✔ Support listedness assessment (for marketed products).
✔ Generate queries to resolve missing/discrepant data.
✔ Submit expedited reports to clients, regulatory agencies, and investigators within deadlines.
✔ Assist in periodic safety report submissions (PSURs, DSURs).
✔ Maintain compliance with SOPs, WIs, and global pharmacovigilance regulations.
✔ Support database reconciliation and document archiving.
✔ Collaborate with cross-functional teams to ensure timely and accurate safety reporting.
About Fortrea
Fortrea is a leading Contract Research Organization (CRO) providing comprehensive clinical development and commercialization services to pharmaceutical, biotechnology, and medical device companies. With a commitment to patient safety and regulatory compliance, Fortrea plays a crucial role in bringing new therapies to market.
Why Join Fortrea?
✅ Global Impact: Work on life-saving drugs and therapies.
✅ Career Growth: Entry-level role with training in pharmacovigilance.
✅ Hybrid Flexibility: Balance office and remote work.
✅ Regulatory Exposure: Learn FDA, EMA, and ICH-GCP guidelines.
Qualifications & Experience
Minimum Required Education:
- Non-Degree + 6 months–1 year of safety experience*
- Associate Degree + 0–6 months of safety experience*
- BS/BA in Life Sciences, Pharmacy, Nursing, or related field
- MS/MA or PharmD (fresh graduates welcome)
*Safety experience includes:
- Processing AE/SAE reports
- Writing narratives & queries
- Working with safety databases (Argus, ARISg, Veeva)
- Regulatory submissions
Relevant experience in:
- Clinical Data Management
- Medical Affairs
- Regulatory Affairs
- Quality Assurance
Skills & Competencies:
🔹 Attention to detail
🔹 Strong written & verbal communication
🔹 Proficiency in MS Office
🔹 Ability to work in a team
🔹 Basic knowledge of MedDRA coding (preferred)
How to Apply
If you meet the qualifications and are interested in this Safety Science Analyst role, apply before the deadline: June 23, 2025.
