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If you’re a pharmacy or life sciences graduate looking to enter the dynamic world of drug safety and pharmacovigilance, Fortrea’s latest opening for a Safety Science Coordinator I in Pune presents a compelling opportunity. This entry-level clinical safety role offers hands-on experience in managing adverse event reports, ensuring regulatory compliance, and contributing to the safe development and monitoring of pharmaceutical products globally.
Why Pharmacovigilance Matters
Pharmacovigilance (PV) plays a critical role in protecting public health by monitoring the safety of medications in clinical trials and post-marketing. As a Safety Science Coordinator, you’ll be directly involved in safeguarding patients by helping to detect, assess, and prevent adverse effects or other drug-related issues.
About the Role
As a Safety Science Coordinator I, you will assist with the clinical safety operations of investigational and marketed products.
Your day-to-day responsibilities will involve handling adverse event (AE) and serious adverse event (SAE) reports, working within global safety databases, preparing regulatory submissions, and ensuring compliance with international health and safety standards.
You will be supporting a wide range of stakeholders including clients, regulatory authorities, ethics committees, investigators, and internal Fortrea teams — all while working within a quality and data-driven environment.
Key Responsibilities
Process and submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Maintain and update adverse event tracking systems and project documentation.
Conduct data entry, write patient narratives, and ensure accurate MedDRA coding.
Assist with regulatory submissions and compliance checks across global markets.
Collaborate cross-functionally and participate in quality reviews and database reconciliations.
Support internal teams through training, meeting coordination, and documentation.
Who Should Apply?
Fortrea is seeking candidates with:
A PharmD, MPharm, or BPharm degree (or related qualifications in medical/ life sciences).
At least 1 year of relevant experience in safety data management, clinical research, or a similar function.
Working knowledge of MedDRA, pharmacovigilance databases, and regulatory frameworks.
Excellent attention to detail, logical thinking, and communication skills.
Proficiency in English and local language (both written and spoken).
Basic to advanced computer skills, including Microsoft Office.
What Makes Fortrea a Great Place to Work
Fortrea is a leading global CRO (Contract Research Organization) dedicated to supporting clinical research and drug development across therapeutic areas. As a member of the Fortrea team, you’ll be part of a company that values quality, compliance, and collaboration.
In addition to building a solid foundation in pharmacovigilance, you’ll gain valuable experience in the broader clinical research and regulatory landscape, preparing you for long-term career growth.
📍 Location
Pune, India
Ready to Apply?
If you’re ready to start your career in drug safety with a purpose-driven organization, this role at Fortrea is your chance to make an impact. Join a growing team that works at the intersection of science, data, and patient care.
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