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Senior Medical Director - Pharmacovigilance/Drug Safety

7+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Remote 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

Parexel is dedicated to improving global health by providing a suite of biopharmaceutical services that help clients transform scientific discoveries into new treatments. We uphold our values of Patients First, Quality, Respect, Empowerment, and Accountability.

We are seeking a Senior Medical Director with extensive experience in Pharmacovigilance/Drug Safety. This newly created role for the EMEA region requires previous team management experience and a desire for further leadership growth.

Job Purpose

The Senior Medical Director will lead the Safety Medical Sciences business functions, providing strategic inputs to Safety Services Leadership while implementing innovative technologies and processes.

Key Responsibilities

  • Maintain in-depth knowledge of adverse events and safety profiles of assigned products, including regulatory obligations and client guidelines.
  • Represent the department at internal and external forums, contributing to thought leadership.
  • Manage resources, ensuring quality, business continuity, and profitability.
  • Collaborate with the Safety Services Leadership Team to provide strategic insights.
  • Perform medical reviews of adverse events and ensure compliance with regulatory timelines.
  • Oversee the writing and review of aggregate reports and safety documents.
  • Manage safety signals and contribute to risk management planning.
  • Prepare and review periodic safety reports in accordance with regulatory requirements.
  • Lead and mentor therapeutic area teams, ensuring the assessment of safety information related to assigned products.

Knowledge and Experience

  • Extensive knowledge of drug safety and clinical trials.
  • Clinical practice experience and managerial leadership skills.
  • Strong understanding of medical terminology.

Education

  • Doctor of Medicine (MD) from an accredited medical school.
  • Completion of basic training in clinical medicine (residency, internship, etc.).

If you're interested in shaping the future of pharmacovigilance at Parexel, we encourage you to apply.