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Clinical Safety Manager- Pharmacovigilance / Drug Safety

4+ years
Not Disclosed
10 Jan. 13, 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

Clinical Safety Manager

Location: India
Company: Medpace


Job Summary

Medpace is looking for a Clinical Safety Manager to join its Clinical Safety Department in India. This full-time role is central to the pharmacovigilance process, offering the chance to apply your nursing or pharmacovigilance expertise in a dynamic environment with growth potential.


Responsibilities

As a Clinical Safety Manager, your key responsibilities will include:

  • Leadership and Mentorship:

    • Line manage, mentor, and develop a team of clinical safety professionals.
  • Client and Stakeholder Engagement:

    • Manage relationships with clients and internal stakeholders, offering expert safety knowledge.
  • Oversight and Quality Assurance:

    • Oversee clinical safety case management and aggregate reporting handled by direct reports.
    • Ensure all deliverables meet high-quality standards to satisfy client needs.
  • Safety Management Plans:

    • Create and implement safety management plans tailored to client requirements.
  • Document Review:

    • Provide safety review of clinical study documents, including protocols, study reports, and marketing application components.

Qualifications

To qualify for this role, you need:

  • Educational Background:

    • Bachelor’s degree in a healthcare-related field (e.g., Nursing, Pharmacy, Pharmacology).
  • Experience:

    • At least 4 years of clinical research or pharmacovigilance experience.
    • A minimum of 1 year of clinical nursing experience.
    • Prior project management experience (preferred).

About Medpace

Medpace is a global clinical contract research organization (CRO) with over 30 years of experience. Specializing in Phase I-IV clinical development services, Medpace partners with the biotechnology, pharmaceutical, and medical device industries to accelerate the global development of safe and effective medical therapeutics. Headquartered in Cincinnati, Ohio, Medpace employs more than 5,000 people across 40+ countries and has expertise across therapeutic areas like oncology, endocrinology, cardiology, and infectious diseases.


Why Medpace?

People. Purpose. Passion.
At Medpace, your work makes a real difference by improving global health outcomes.

Perks and Benefits:

  • Flexible work environment
  • Competitive compensation and benefits
  • Generous PTO packages
  • Structured career growth opportunities
  • Company-sponsored employee appreciation events
  • Health and wellness initiatives

Awards and Recognition

  • Recognized by Forbes as one of America's Most Successful Midsize Companies (2021–2024).
  • Awarded CRO Leadership Awards for expertise, quality, and reliability by Life Science Leader magazine.

What to Expect Next

If your qualifications meet the requirements, a Medpace representative will contact you to guide you through the next steps in the application process.

Apply Today to advance your career and contribute to life-changing medical developments.


Medpace is an Equal Opportunity/Affirmative Action Employer. We encourage applications from individuals of all backgrounds, including those with disabilities, veterans, and other underrepresented groups.