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Clinical Safety Manager - Pharmacovigilance / Drug Safety

2+ 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: Munich, Germany
Department: Clinical Safety
Job ID: 9606


Overview

Medpace is expanding its European Pharmacovigilance (PV) operations and seeks a highly skilled Clinical Safety Manager to join its Munich team. This office-based role is vital to managing pharmacovigilance processes and ensuring quality and compliance across multiple clinical safety programs.

This position offers an opportunity to leverage your expertise while advancing your career in a collaborative and high-performing environment.


Key Responsibilities

  • Program Management:

    • Oversee clinical safety activities across multiple large programs.
    • Create tailored Safety Management Plans for various clients.
  • Stakeholder Engagement:

    • Manage relationships with clients and internal stakeholders by providing expert safety knowledge.
    • Participate in business development activities such as presentations, audits, and scope generation.
  • Regulatory Compliance and Documentation:

    • Supervise clinical safety case management and aggregate reporting.
    • Review safety aspects of clinical study documents (e.g., protocols, study reports, marketing application components).
    • Write and maintain departmental SOPs, Work Instructions, and PSMF documents.
  • Leadership and Training:

    • Provide mentorship and motivational support to the clinical safety team.
    • Drive continuous improvement initiatives to meet client and regulatory expectations.

Qualifications

  • Education:

    • Bachelor’s degree with a minimum of 5 years of clinical safety experience, including project and line management; OR
    • Master’s degree with a minimum of 3 years of experience.
  • Professional Experience:

    • Proven expertise in managing clinical safety activities for multiple programs.
    • Experience with CCDS, RMP, SmPC writing, and maintenance.
    • Knowledge of global clinical safety regulatory requirements.
  • Key Skills:

    • Strong communication (verbal and written) and interpersonal skills.
    • Leadership, mentorship, and motivational abilities.
    • Ability to work independently and collaborate effectively within a team.

Why Join Medpace?

Benefits and Perks

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

Global Impact

  • Medpace has been advancing therapeutic innovations for 30+ years.
  • Recognized as one of America’s Most Successful Midsize Companies (Forbes, 2021–2024).
  • Award-winning quality and reliability in clinical research.

Application Process

Applicants are requested to submit their resumes in English.

Be a part of Medpace and contribute to the development of transformative therapeutics that improve the quality of life for patients worldwide.

Apply now for Job ID 9606 and make an impact!