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Vice President, Drug Safety / Pharmacovigilance

Position Summary:

Reporting to the CMO, the Vice President, Drug Safety/Pharmacovigilance (PV) will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company’s development and commercial activities, industry standards, and compliance with global regulations. S/he will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data. This position will also be a member of the Development Leadership Team.

Essential Functions:

  • Oversees and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and marketed products; actively participates in oversight of patient safety in all clinical trials.
  • Designs, directs and conducts ongoing safety surveillance of company drug products to ensure delivery of high-quality pharmacovigilance services.
  • Negotiates contracts, interacts and supervises the activities of CROs and consultants for pharmacovigilance services.
  • Provides ongoing updates to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans.
  • Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products.
  • Provides oversight of all clinical safety activities including review of medical coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (ASE) for unexpected and related serious adverse events (SUSARs) from clinical trials
  • Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
  • Directs the development, preparation and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates, etc...), investigator communications, product labeling/package inserts and other reports as necessary.
  • Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
  • Ensures departmental budgets and schedules to effectively meet corporate goals.
  • Manage internal team and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.
  • Monitors industry best practices and changes in global safety regulations and guidelines.

Preferred Experience:

  • 10+ years extensive management experience in pharmaceutical safety including a thorough understanding of case processing and other pharmacovigilance processes.
  • Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents; expertise in global safety regulations.
  • Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities.

Preferred Education:

  • MD or equivalent.

Preferred Skills:

  • Actively drives strong teamwork and collaboration with an enterprise-wide perspective.
  • Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
  • Superior communication skills, verbal and written.
  • A positive, resilient individual with a 'can' do attitude and able to deliver solutions.
  • Ability to navigate and demonstrate success in a fast paced, dynamic work environment which requires the collaboration of multiple people various functions.
  • Sound strategic evaluation, analysis, and decision-making skills.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally.
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