Safety Science Coordinator II – Drug Safety & Pharmacovigilance (Pune)
Location: Pune, India
Category: Clinical Safety & PV
Experience Level: 2+ Years
Job Type: Full-Time
Work Mode: On-site or Hybrid (as per project)
Job Summary
Fortrea is seeking a skilled Safety Science Coordinator II to support the end-to-end adverse event case processing across clinical and post-marketing studies. The role involves managing safety data, coding with MedDRA, ensuring regulatory compliance, and collaborating with PV and clinical teams. Ideal for professionals with strong pharmacovigilance knowledge and attention to quality and timelines.
Key Responsibilities
Manage receipt, tracking, and processing of adverse event (AE) reports
Perform data entry, MedDRA coding, narrative writing, and case assessments
Identify missing clinical data and initiate follow-ups or medical reviews
Ensure compliance with regulatory and client-specific timelines
Submit expedited and periodic safety reports to authorities and clients
Assist with database reconciliation and project documentation
Maintain study files, tracking systems, and project metrics
Support peer quality checks and mentor junior staff
Participate in audit readiness, SOP compliance, and client meetings
Adhere to GVP and pharmacovigilance documentation standards
Required Skills & Qualifications
PharmD/MPharm/BPharm or degree in Pharmacy, Nursing, Life Sciences
Minimum 2 years of pharmacovigilance experience
Strong knowledge of case processing, narrative writing, MedDRA
Familiarity with global PV regulations and expedited reporting standards
Attention to detail and ability to meet strict deadlines
Good verbal and written communication skills
Proficiency in MS Office and safety databases
Ability to work independently and as part of a team
Mentoring and peer-review experience is a plus
Perks & Benefits
Opportunity to work on global pharmacovigilance projects
Exposure to diverse safety databases and regulatory systems
Collaborative work environment with training opportunities
Health and wellness benefits
Career growth in a top-tier clinical research organization
Company Description
Fortrea is a global Contract Research Organization (CRO) delivering end-to-end clinical development and technology solutions. With over 20 therapeutic areas and operations in 100+ countries, Fortrea supports leading pharmaceutical and biotechnology clients by advancing innovative treatments through rigorous clinical research and safety science practices.
Work Mode
On-site (Pune) or Hybrid, based on project requirements
Call to Action
Join Fortrea and be part of a global mission to deliver safe and effective therapies. If you’re experienced in pharmacovigilance and clinical safety, apply now and accelerate your career in a world-class CRO.
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