MPharm Jobs at Fortrea | Apply Now for the Safety Science Coordinator Role
Fortrea is hiring a Safety Science Coordinator I in Pune, India (Hybrid). In this role, you will support clinical safety operations, process adverse event data, prepare regulatory submissions, and ensure compliance with global safety standards. This position is ideal for life sciences graduates with safety experience who want to build a career in pharmacovigilance and clinical research.
- Job Title: Safety Science Coordinator I
- Location: Pune, India (Hybrid)
- Job ID: 253818
Job Overview
As a Safety Science Coordinator I, you will assist with clinical safety and pharmacovigilance operations for clinical trials and post-marketing products. You will manage adverse event (AE/SAE) reporting, prepare safety submissions, and ensure timely and compliant communication with clients, regulatory authorities, ethics committees, and investigators.
Key Responsibilities
- Assist in the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project files.
- Ensure all AE/SAE reports are logged and processed within study timelines.
- Write patient narratives, code adverse events with MedDRA, and conduct listedness assessments.
- Generate and manage safety queries in consultation with medical staff.
- Submit SAE reports to clients, regulators, and other stakeholders.
- Support peer review of safety reports, trend analysis, and database reconciliations.
- Ensure compliance with SOPs, Work Instructions (WIs), and regulatory requirements.
- Prepare safety study files for archiving.
- Train and mentor PSS Assistants or peers.
- Build strong cross-functional relationships within PSS teams.
Qualifications
- Education: PharmD, MPharm, BPharm, or equivalent.
- Experience: At least 1 year of relevant experience in pharmacovigilance, safety reporting, or related areas (CRO, pharma, biotech).
- Preferred Backgrounds: Pharmacy, Nursing, Medical Sciences, Life Sciences.
Skills & Competencies:
- Hands-on experience with AE/SAE processing, safety databases, and regulatory submissions.
- Strong written and verbal communication in English and local language.
- Good attention to detail, logical thinking, and proofreading skills.
- Proficiency with MS Office and safety databases.
- Ability to prioritize tasks, manage multiple projects, and work in a team.
Work Environment
- Hybrid (Office & Remote)
- Standard office hours with flexibility as per project needs.
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