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Safety Science Coordinator Ii

2+ years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.