If you’re looking to build a career in pharmacovigilance and clinical safety operations, this is your chance. Fortrea is hiring a Safety Science Specialist in Pune. This full-time role offers an opportunity to contribute to drug safety, adverse event reporting, and regulatory submissions—critical areas in global healthcare compliance.
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Key Responsibilities
As a Safety Science Specialist, you will be responsible for:
- Managing receipt and processing of adverse event (AE) and serious adverse event (SAE) reports from both clinical trials and post-marketing sources.
- Performing data entry, narrative writing, MedDRA coding, and case review.
- Ensuring completeness and accuracy of safety data for regulatory submissions.
- Preparing follow-up queries and correspondence in consultation with medical staff.
- Submitting expedited SAE reports to clients, regulatory authorities, and ethics committees.
- Supporting periodic and expedited safety reports (PSRs, ESRs).
- Assisting in database reconciliation with data management teams.
- Conducting quality reviews and supporting root cause analysis/CAPA plans.
- Participating in audits, inspections, and safety committee/DSMB activities.
- Maintaining up-to-date knowledge of SOPs, guidelines, and pharmacovigilance directives.
Required Qualifications
- Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, or Life Sciences (preferred).
- Experience requirements vary by degree:
- Non-degree: 3–4 years of relevant experience.
- Associate degree: 2–3 years of safety or relevant experience.
- BS/BA: 1–2 years of safety experience.
- MS/MA/PharmD: 1+ years of safety or relevant industry experience.
- Knowledge of pharmacovigilance processes, adverse event reporting, and safety databases.
- Strong attention to detail, communication skills, and ability to work independently.
- Familiarity with MS Office, clinical data management, regulatory affairs, or QA is an advantage.
Why Join Fortrea?
- Work in a global CRO environment with exposure to international safety regulations.
- Build expertise in clinical safety operations and pharmacovigilance reporting.
- Opportunities for career growth in regulatory and drug safety functions.
- Hybrid/office environment with professional development support.
How to Apply
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