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Clinical Safety Manager - Pharmacovigilance / Drug Safety

2-5 years
Preferred by Comapny
10 Nov. 25, 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: Stirling, United Kingdom
Department: Clinical Safety
Job ID: 10194


Overview

Medpace, a globally recognized clinical contract research organization (CRO), is seeking an experienced Clinical Safety Manager to join its expanding UK team in Stirling. This full-time, office-based position is critical in driving pharmacovigilance processes and overseeing safety activities for multiple programs.

If you are looking to leverage your expertise in clinical safety, manage large programs, and grow within an innovative and global organization, this opportunity is for you.


Key Responsibilities

  • Oversee clinical safety activities for multiple large-scale programs.
  • Manage relationships with clients and internal teams, providing expert safety insights.
  • Ensure high-quality execution of clinical safety case management and aggregate reporting.
  • Perform safety reviews for clinical study documents, including protocols, reports, and marketing application components.
  • Develop and implement safety management plans tailored to client needs.
  • Contribute to business development, including:
    • Presentations for prospective sponsors.
    • Participation in sponsor audits.
    • Drafting scopes of work and cost estimates.
  • Write and maintain departmental SOPs and Work Instructions.

Qualifications

  • Education:

    • Bachelor’s degree (or equivalent) with significant clinical safety experience.
  • Experience:

    • Expertise in managing clinical safety activities for multiple programs.
    • Proven ability in drafting SOPsWork Instructions, and PSMFs.
    • Experience in CCDSRMP, and SmPC writing and maintenance.
    • Comprehensive knowledge of global clinical safety regulatory requirements.
    • Project management experience; line management experience is a plus.
  • Skills:

    • Strong leadership, mentoring, and motivational skills.
    • Excellent verbal and written communication abilities.
    • Exceptional teamwork and independent working capabilities.

Why Join Medpace?

Perks and Benefits

  • Flexible work environment.
  • Competitive compensation and benefits.
  • Generous Paid Time Off (PTO) packages.
  • Opportunities for professional growth through structured career paths.
  • Participation in employee wellness programs and appreciation events.

Global Impact and Recognition

  • Over 30+ years of experience advancing therapeutic solutions.
  • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
  • Recipient of multiple CRO Leadership Awards for quality and reliability.

How to Apply

Interested candidates can apply for Job ID 10194 through the Medpace Career Portal.

Be part of a team that is transforming healthcare globally while advancing your career in clinical safety and pharmacovigilance.