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Clinical Safety Manager- Pharmacovigilance / Drug Safety

4+ years
Not Disclosed
12 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

Clinical Safety Manager - Pharmacovigilance / Drug Safety
Location: Navi Mumbai, India
Job ID: 10023

Job Summary:
Medpace is expanding its clinical operations and is seeking a full-time Clinical Safety Manager to join the Clinical Safety Department in Navi Mumbai. This role plays a pivotal role in the pharmacovigilance process. If you have a background in nursing or pharmacovigilance and want to advance your career, this is a great opportunity for you.

Responsibilities:

  • Line manage, mentor, and develop a team of clinical safety professionals.
  • Manage relationships with clients and internal stakeholders, providing expert safety knowledge.
  • Oversee clinical safety case management and aggregate reporting responsibilities of direct reports, ensuring high-quality client service.
  • Develop safety management plans tailored to client needs.
  • Review clinical study documents, including protocols, study reports, and marketing application components for safety.

Qualifications:

  • Bachelor’s degree in a healthcare-related field (Nursing, Pharmacy, Pharmacology, etc.).
  • At least 4 years of experience in clinical research or pharmacovigilance.
  • At least 1 year of clinical nursing experience.
  • Prior project management experience is preferred.

Medpace Overview:
Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through scientific expertise.

Why Medpace?

  • Flexible work environment
  • Competitive compensation and benefits
  • 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 and contribute to making a difference in global healthcare while advancing your career.