Executive Director, Drug Safety and Risk Management

vor 3 Wochen

Luzern, Luzern, Schweiz Organon Vollzeit
Job Description

Overview

Organon is seeking an experienced Executive Director to lead our Drug Safety and Risk Management team. As a key member of our Global Pharmacovigilance and Safety Science (GPSS) Department, you will be responsible for setting and implementing the overall safety strategy and procedures for our assigned therapeutic area product portfolio.

Key Responsibilities

  • Develop and implement a comprehensive safety strategy that aligns with company objectives and regulatory requirements.
  • Lead interactions with Organon governance committees and regulatory agencies to ensure compliance with safety regulations and guidelines.
  • Build strong relationships with cross-functional teams to ensure alignment of safety strategy with development, regulatory, and medical strategies.
  • Ensure timely and high-quality aggregate safety reports, response to questions, and other scientific reports are prepared and submitted to regulatory authorities.
  • Provide scientific expertise to organization, including interdisciplinary developmental teams and post-marketing teams.
  • Act as key-SME during inspections and represent GPSS and safety topics in Health Authority meetings.
  • Manage vendor activities related to safety tasks and ensure compliance with regulations.
  • Ensure continuous safety profile monitoring, signal detection, and benefit/risk evaluations, including initiating appropriate measures.
  • Active involvement in and oversight of PASS/PAES or other safety studies.

Requirements

  • Medical degree, ideally with clinical experience in a relevant field.
  • 10+ years of experience in the pharmaceutical industry, with 5-10+ years in drug safety and pharmacovigilance.
  • Extensive knowledge of PV deliverables, standards, and processes at a global level.
  • Knowledge and experience in Pharmacoepidemiology and Benefit-Risk profile process implementation.
  • Comprehensive knowledge of pharmacovigilance and clinical trial legislations and regulations.
  • Excellent verbal and written communication skills, analytical skills, and demonstrated leadership skills.
  • Able to build and maintain good relationships with a strong customer focus.
  • Fluency in English.

Preferred Experience

  • Board Certification.

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