Executive/Senior Medical Director, Pharmacovigilance & Drug Safety

139968
  • Competitive
  • Boston, United States
  • Permanent

An exciting opportunity with a pioneering pharmaceutical company dedicated to advancing healthcare through innovative drug development within Neurology. With a focus on breakthrough therapies, striving to improve the lives of patients worldwide.

Position Overview:

This innovative organization is looking to bring on a highly experienced and dynamic Senior Medical Director to lead our Pharmacovigilance & Drug Safety team. This pivotal role will involve overseeing the safety profile of our pharmaceutical products throughout their lifecycle, ensuring compliance with regulatory standards, and driving continuous improvement in safety monitoring processes.

 

Responsibilities:

  • Provide strategic leadership and direction for pharmacovigilance and drug safety activities.
  • Develop and implement pharmacovigilance processes and systems to ensure the timely and accurate assessment of safety data.
  • Collaborate cross-functionally with clinical development, regulatory affairs, and other departments to integrate safety considerations into product development plans.
  • Lead the evaluation of safety signals, conduct risk assessments, and implement risk management strategies.
  • Oversee the preparation and submission of safety reports to regulatory authorities in compliance with regulatory requirements.
  • Serve as the primary point of contact for safety-related inquiries from regulatory agencies, healthcare professionals, and internal stakeholders.
  • Mentor and develop team members, fostering a culture of excellence and continuous learning within the pharmacovigilance department.

Qualifications:

  • Medical degree (MD) or equivalent advanced degree in life sciences.
  • Board certification or equivalent experience in pharmacovigilance and drug safety.
  • Extensive experience in pharmacovigilance within the pharmaceutical industry, with a strong understanding of global regulatory requirements.
  • Proven leadership skills with the ability to inspire and motivate teams.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional areas and with external partners.
  • Strong analytical and problem-solving abilities, with a keen attention to detail.
  • Demonstrated ability to drive results in a fast-paced and dynamic environment.
Vanessa Eatz Division Manager

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