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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: BBA/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: London, UK
Company: Medpace


Job Summary

Our European operations are expanding rapidly, and we are seeking a Clinical Safety Manager to join our team in London, UK. This full-time, office-based role is instrumental in driving pharmacovigilance processes and ensuring the success of critical safety initiatives. Collaborating with a talented team, you will contribute to the delivery of high-quality safety management solutions while advancing your career in a dynamic and supportive environment.


Responsibilities

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

Qualifications

  • Bachelor’s degree or equivalent, with substantial clinical safety experience, including project and line management.
  • Proven expertise in managing clinical safety activities across multiple programs.
  • Proficiency in drafting and updating departmental SOPs and Work Instructions.
  • Experience with PSMF generation and maintenance.
  • Competence in CCDS, RMP, and SmPC creation and maintenance.
  • Strong understanding of global clinical safety regulatory requirements.
  • Excellent verbal and written communication skills.
  • Leadership abilities with a proven track record of mentoring and motivating teams.
  • Exceptional teamwork and collaboration skills.
  • Ability to work independently and manage complex projects effectively.

About Medpace

Medpace is a leading clinical contract research organization (CRO) providing Phase I-IV clinical development services. With over 30 years of experience, we specialize in accelerating the development of safe and effective medical therapeutics. Our therapeutic expertise spans major areas, including oncology, cardiology, metabolic disease, endocrinology, and central nervous system disorders.


Why Medpace?

People. Purpose. Passion.

At Medpace, our work improves the lives of patients and families globally. Join us to make a meaningful impact while growing your career.

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).
  • Winner of CRO Leadership Awards for expertise, quality, and reliability.

What to Expect Next

A Medpace representative will review your qualifications. If selected, you will be contacted regarding the next steps.

Apply Today to join our team and advance global medical research.

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