Fortrea is Hiring Pharma Graduates for the Safety Science Coordinator Role | Apply Now
Fortrea is hiring a Safety Science Coordinator I in Pune, India, to support clinical safety and pharmacovigilance operations for global projects. If you are seeking a pharma job, this role involves managing and processing adverse event reports from both clinical trials and post-marketing settings, ensuring compliance with regulatory requirements, and delivering accurate safety data to clients and health authorities. Ideal for professionals with a background in pharmacy and safety operations, this position offers the opportunity to contribute to patient safety worldwide while developing your expertise in drug safety, regulatory submissions, and pharmacovigilance practices.
- Job Position: Safety Science Coordinator I
- Location: Pune, India
- Job ID: 254799
- Job Type: Full-time
About the Company:
Fortrea is a leading global Contract Research Organization (CRO) dedicated to transforming the development of drugs and medical devices. For those seeking a career in the pharmaceutical industry, Fortrea stands as a hub of excellence. With decades of expertise in clinical trials, pharmacovigilance, and regulatory solutions, Fortrea partners with pharmaceutical and biotechnology companies to accelerate the delivery of innovative therapies to patients worldwide. The company is committed to operational excellence, compliance with global standards, and fostering a culture of growth and collaboration for its employees.
Job Description:
The Safety Science Coordinator will assist with the various tasks inherent to a pharmaceutical job, including end-to-end clinical safety and Pharmacovigilance Safety Services (PSS) operations. This includes processing adverse event (AE) and serious adverse event (SAE) reports, preparing narratives, supporting regulatory submissions, and maintaining accurate safety databases. The role requires strong attention to detail, adherence to safety regulations, and collaboration with cross-functional teams to ensure high-quality deliverables within established timelines.
Key Responsibilities:
- Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project files.
- Log AE/SAE reports into safety databases and ensure timely forwarding.
- Perform data entry, patient narratives, coding using MedDRA, and listedness assessments.
- Generate queries to resolve discrepancies in consultation with medical staff.
- Submit SAE reports to clients, regulatory bodies, ethics committees, investigators, and vendors.
- Support reconciliation of databases and peer review of processed reports.
- Assist in archiving safety study files and scheduling meetings.
- Mentor junior staff and build strong PSS team relationships.
- Ensure compliance with SOPs, work instructions, and regulatory requirements.
Educational Qualifications:
BPharm, MPharm, or PharmD.
Experience and Skills
- At least 2 years of safety or relevant pharmaceutical/CRO experience.
- Knowledge of adverse event/SAE processing, safety databases, and regulatory submissions.
- Strong communication (written and spoken English and local language).
- Attention to detail, logical reasoning, and proofreading accuracy.
- Proficiency with MS Office and data handling.
- Ability to prioritize, multitask, and work as part of a team within a pharma job environment.
Keywords: Safety Science, Coordinator jobs Pune, Fortrea careers, Pharmacovigilance jobs, Drug safety associate, Clinical safety coordinator
