Fortrea, a global leader in clinical research and drug safety solutions, is hiring Assistant I PSS in Pune. This hybrid role offers a unique opportunity to contribute to pharmacovigilance, patient safety services (PSS), and regulatory compliance while building a rewarding career in the life sciences and pharmaceutical industry.
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If you are a graduate in pharmacy, life sciences, or medical sciences, with strong attention to detail and an interest in safety operations, this role is a perfect entry point into the world of pharmacovigilance and drug safety monitoring.
Key Responsibilities
As an Assistant I PSS at Fortrea, you will:
- Perform case intake and triage of safety information from clinical trials and post-marketing settings.
- Enter adverse event data into safety tracking systems.
- Write patient narratives and accurately code adverse events using MedDRA.
- Assist in listedness assessment against product labels (for marketed products).
- Generate queries and collect missing information in consultation with medical staff.
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and vendors.
- Support periodic safety reporting and ensure compliance with regulatory timelines.
- Assist in database reconciliation and maintain adverse event reporting documentation.
- Build effective cross-functional relationships within PSS teams.
- Comply with SOPs, Work Instructions, and Quality Management frameworks.
Qualifications & Skills
Candidates should have:
- Education:
- Non-degree with 6 months – 1 year of safety/relevant experience, OR
- Associate, BS/BA, MS/MA, or PharmD in Biological Sciences, Pharmacy, Nursing, Life Sciences, or related field (0–6 months experience accepted).
- Experience (preferred but not mandatory):
- Prior pharmacovigilance, clinical data management, regulatory affairs, or quality assurance exposure.
- Skills:
- Strong attention to detail and accuracy.
- Excellent written and verbal communication.
- MS Office proficiency.
- Ability to proof-read numerical data and work in team environments.
Benefits of Joining Fortrea
- Hybrid work model (office + remote flexibility).
- Exposure to global pharmacovigilance practices.
- Opportunity to grow within clinical safety and drug development.
- Work in a supportive and compliance-driven environment.
How to Apply
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