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Drug Safety Specialist/ Clinical Safety Coordinator

3+ years
Not Disclosed
10 May 1, 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

Drug Safety Specialist / Clinical Safety Coordinator
Location: Navi Mumbai, India
Department: Clinical Safety
Job ID: 10603

Job Summary:
Medpace is currently hiring a full-time, office-based Clinical Safety Coordinator to join its Clinical Safety team in India. This role is central to the handling and processing of adverse events from both clinical trials and post-marketing surveillance. Ideal for candidates seeking to expand their expertise in drug safety while contributing to meaningful global healthcare outcomes.

Responsibilities:

  • Determine the appropriate plan of action for incoming safety-related calls.

  • Collect, process, and monitor adverse and serious adverse events (AEs and SAEs).

  • Compose detailed and compliant safety narratives.

  • Generate reports based on various safety data sets.

  • Collaborate with internal departments and clinical research sites to ensure adherence to safety protocols and regulatory compliance.

Qualifications:

  • Bachelor’s degree in a healthcare-related field such as Nursing, Pharmacy, or Pharmacology.

  • Clinical experience or background in clinical research, case processing, or post-marketing pharmacovigilance preferred.

  • Proficient in English (verbal and written).

  • Strong working knowledge of Microsoft Office.

  • Broad understanding of medical terminology.

  • Excellent organizational and communication skills.

About Medpace:
Medpace is a leading full-service clinical contract research organization (CRO), providing comprehensive Phase I-IV development services to pharmaceutical, biotechnology, and medical device companies. Headquartered in Cincinnati, Ohio, and operating in over 40 countries, Medpace is committed to accelerating the development of life-saving medical treatments through scientific excellence and global collaboration.

Why Join Medpace?

  • Flexible work environment

  • Competitive compensation and benefits

  • Generous PTO structure

  • Structured career development opportunities

  • Employee appreciation initiatives

  • Comprehensive wellness programs

Awards and Recognition:

  • Listed by Forbes as one of America’s Most Successful Midsize Companies (2021–2024)

  • Recipient of multiple CRO Leadership Awards by Life Science Leader magazine

Next Steps:
If your qualifications match, a Medpace team member will reach out to discuss the next steps in the hiring process.

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