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Clinical Safety Manager- Pharmacovigilance / Drug Safety

Medpace
Medpace
1-4 years
Not Disclosed
10 Dec. 20, 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

Job Opening: Clinical Safety Manager - Pharmacovigilance / Drug Safety

Location: Navi Mumbai, India
Department: Clinical Safety
Job ID: 10023
Job Type: Full-Time

Job Summary:
Medpace is seeking a Clinical Safety Manager to join our Clinical Safety Department in Navi Mumbai, India. This full-time position offers a fantastic opportunity to play a critical role in the pharmacovigilance process, leveraging your expertise in nursing or pharmacovigilance while growing in your career.

Responsibilities:

  • Lead, 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 for direct reports, ensuring high-quality fulfillment of client needs.
  • Develop safety management plans based on client requirements.
  • Provide safety review for clinical study documents, including protocols, study reports, and marketing application components.

Qualifications:

  • Bachelor's degree in a healthcare-related field such as Nursing, Pharmacy, Pharmacology, or similar.
  • Minimum of 4 years of experience in clinical research or pharmacovigilance.
  • At least 1 year of clinical nursing experience.
  • Project management experience is preferred.

About Medpace:
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. We aim to accelerate the global development of safe and effective medical therapeutics using a scientific and disciplined approach.

Why Medpace?

  • People. Purpose. Passion. Join us today and make a difference tomorrow.
  • Recognized by Forbes as one of America's Most Successful Midsize Companies (2021, 2022, 2023, and 2024).
  • Continually honored with CRO Leadership Awards for expertise, quality, capabilities, reliability, and compatibility.

Medpace Perks:

  • 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

How to Apply:
Ready to take the next step in your career? Apply today to join Medpace and be part of our mission to improve global health.