Latest PharmD Jobs at Fortrea | Apply Now for Safety Science Coordinator Role
Looking to take the next step in your pharmacovigilance career? Fortrea is hiring a Safety Science Coordinator II in Pune. With a strong focus on clinical safety and regulatory compliance, this full-time position offers the chance to work with global clients in managing adverse event reports and supporting patient safety operations. If you have a PharmD, MPharm, or BPharm and at least 2 years of relevant experience, don’t miss your opportunity—apply before August 13, 2025!
About the Company
Fortrea is a global leader in clinical research and drug development services, dedicated to transforming the future of healthcare. With a strong foundation in clinical safety, regulatory compliance, and patient-centered innovation, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to accelerate the delivery of life-changing therapies. Operating in more than 90 countries, Fortrea combines scientific expertise with cutting-edge technology to support every phase of the drug development lifecycle. Committed to excellence and integrity, Fortrea empowers professionals to make a meaningful impact on global health.
Job Details
Position: Safety Science Coordinator II
Location: Pune
Time Type: Full-time
End Date: August 13, 2025 (5 days left to apply)
Job Requisition ID:
253907Qualifications (Minimum Required):
PharmD/Mpharm/Bpharm + 2 years of relevant experience.
Degree preferred to be in one or more of the following disciplines:
Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
Experience (Minimum Required):
- High degree of accuracy with attention to detail;
- Functions as a team player and offers peer support as needed;
- Good written and verbal communication skills;
- Ability to work independently with moderate supervision;
- Good keyboard skills with knowledge of MS Office and Windows applications would be beneficial.
- Mentoring skills preferred.
Job Overview:
Assist with the overall Clinical Safety and/or PSS operations associated with products, including the adverse events process, which may include safety data collected from clinical trials and/or post-marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. Responsible for providing this service to clients either as a support function to the client project groups or as a standalone business. Responsible for providing all clients, both internal and external, with the appropriate quality of service safely and cost-effectively. He/she will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989, and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Summary of Responsibilities:
Process the adverse event reports from any source as per the client/sponsor-agreed plans.
Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or a clinical trial. This includes, but is not limited to:
- Data entry of safety data onto adverse event database(s) and tracking systems;
- Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting;
- Write patient narratives and code adverse events accurately using MedDRA, if applicable, to determine lists against the appropriate label (for Marketed products, if applicable);
- Identify clinically significant information missing from initial reports and generate queries for its collection, consulting the medical staff if needed;
- Ensure the case receives appropriate medical review.
- Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners, and Fortrea project personnel, if required and as agreed with the client during study set-up, within study-specified timelines; and more.
- Assist with quality review or peer review of the processed reports.
- Assist and/or complete the database reconciliation and the associated activities, as applicable.
- Maintain study/project-level documentation as per the agreed requirements, as applicable.
- Support with training of PSS staff and mentor the team as needed.
Support with input required for monthly status reports, assist in the generation and maintenance of the PSS metrics (if needed), and more.
Keywords: Job Posting, Safety Science Coordinator II, Pune, Full-time, PharmD, Mpharm, Bpharm, Clinical Safety, Pharmacovigilance, Latest PharmD Jobs, Pharma Jobs at Fortrea, Latest Pharma Jobs at Fortrea, Regulatory Compliance, Job Posting
