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Drug Safety Specialist

Medpace
Medpace
0-2 years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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
Location: Navi Mumbai, India
Job ID: 10022

Job Summary:
Medpace is seeking a full-time, office-based Drug Safety Specialist to join our Clinical Safety department in Navi Mumbai. This role is focused on the processing and management of adverse events from all sources, including clinical trials and post-marketing surveillance. If you're looking for an exciting opportunity to leverage your expertise and advance your career, this position could be the right fit for you.

Responsibilities:

  • Determine action plans for incoming adverse event calls.
  • Collect, process, and track adverse and serious adverse events.
  • Write safety narratives for documentation.
  • Report on various safety data and ensure compliance.
  • Collaborate with internal teams and clinical research sites to maintain safety protocols.

Qualifications:

  • Bachelor’s degree in a healthcare-related field (Nursing, Pharmacy, Pharmacology, etc.).
  • Clinical experience or expertise in clinical research, case processing, and post-marketing pharmacovigilance preferred.
  • Proficient in English with strong communication skills.
  • Proficient in Microsoft Office.
  • Solid knowledge of medical terminology and strong organizational skills.

Medpace Overview:
Medpace is a global, full-service clinical contract research organization (CRO) offering Phase I-IV clinical development services for the biotechnology, pharmaceutical, and medical device industries. We aim to accelerate the global development of safe and effective medical therapeutics through scientific and disciplined approaches.

Why Medpace?

  • Flexible work environment
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with growth opportunities
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021-2024)

Join Medpace to contribute to improving global healthcare and enhancing patient safety.