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Clinical Safety Manager - Pharmacovigilance / Drug Safety

0-2 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: Stirling, UK
Company: Medpace


Job Summary

Our European operations are expanding rapidly, and we are seeking a full-time Clinical Safety Manager to join our team in Stirling, UK. This role is pivotal in overseeing pharmacovigilance processes and ensuring high-quality safety standards for our clients. Working alongside a dynamic team, you will contribute to the success of critical clinical safety projects while furthering your career in a supportive and growth-oriented environment.


Responsibilities

  • Manage clinical safety activities and multiple large-scale programs.
  • Build and maintain relationships with clients and internal stakeholders, providing expert safety insights.
  • Oversee clinical safety case management and aggregate reporting to meet client needs with high quality.
  • Conduct safety reviews of clinical study documents, including protocols, study reports, and marketing application components.
  • Develop and implement safety management plans tailored to client requirements.
  • Participate in business development activities such as:
    • Presentations to potential sponsors.
    • Participation in sponsor audits.
    • Generation of scopes of work and cost estimates.
  • Author and revise departmental SOPs and Work Instructions.

Qualifications

  • Bachelor’s degree or equivalent, with extensive clinical safety experience, including project management and line management.
  • Proven track record of managing clinical safety activities across multiple programs.
  • Expertise in writing departmental SOPs and Work Instructions.
  • Experience in generating and maintaining PSMFs.
  • Proficiency in CCDS, RMP, and SmPC creation and maintenance.
  • Comprehensive understanding of global clinical safety regulatory requirements.
  • Strong verbal and written communication skills.
  • Leadership abilities with excellent mentoring and motivational skills.
  • Exceptional teamwork and collaboration skills.
  • Ability to work independently and manage complex projects effectively.

About Medpace

Medpace is a full-service clinical contract research organization (CRO) dedicated to accelerating the development of safe and effective medical therapeutics. With over 30 years of expertise, we provide Phase I-IV clinical development services across major therapeutic areas, including oncology, cardiology, endocrinology, and more.


Why Join Medpace?

People. Purpose. Passion.

At Medpace, our work directly improves the lives of patients and families worldwide.

Benefits and Perks:

  • Flexible work environment.
  • Competitive compensation and PTO packages.
  • Structured career development paths.
  • Employee wellness programs.
  • Company-sponsored appreciation events.

Awards and Recognition

  • Named one of America’s Most Successful Midsize Companies by Forbes (2021–2024).
  • Recipient of CRO Leadership Awards for expertise, quality, and reliability.

What to Expect Next

A Medpace team member will review your qualifications. If selected, you will be contacted with details about the next steps.

Apply Today to join Medpace and contribute to groundbreaking medical advancements.

Medpace is an Equal Opportunity Employer, welcoming candidates from diverse backgrounds, including veterans and persons with disabilities.