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Clinical Safety Manager- Pharmacovigilance / Drug Safety

4+ 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

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

Job Summary:
Medpace is seeking a full-time Clinical Safety Manager to join our Clinical Safety Department in Navi Mumbai. This role plays a key role in the pharmacovigilance process at Medpace. If you have expertise in nursing or pharmacovigilance and are looking for an opportunity to grow your career, this is the position for you.

Responsibilities:

  • Line manage, mentor, and develop a team of clinical safety professionals.

  • Build and maintain relationships with clients and internal stakeholders by providing expert safety knowledge.

  • Oversee clinical safety case management and aggregate reporting responsibilities to ensure high-quality service to clients.

  • Create safety management plans tailored to client needs.

  • Provide safety reviews for clinical study documents, including protocols, study reports, and marketing application components.

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 preferred.

Medpace Overview:
Medpace is a 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 a disciplined approach.

Why Medpace?

  • Flexible work environment

  • Competitive compensation and benefits package

  • Competitive PTO packages

  • Structured career paths with opportunities for professional growth

  • 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 be part of our mission to enhance global healthcare through innovative pharmacovigilance solutions.