Director, Pharmacovigilance

Leap Therapeutics is seeking motivated individuals with drug safety/pharmacovigilance experience to be part of a growing oncology company. Successful candidates will work within a highly collaborative team environment to assist in developing and implementing operational plans designed to meet project timelines and the company’s business objectives.

Director, Pharmacovigilance
Reports to the VP of Clinical Development

 

Responsibilities

Reporting to the VP of Clinical Development, the Director will lead the strategic management, planning and execution of clinical pharmacovigilance and risk management activities for Leap clinical development programs in compliance with regulatory guidelines. This individual will be responsible for the development and implementation of signal expertise through contributions to clinical deliverables and activities. The Director will provide scientific/clinical expertise, strategic input, and manage deliverables associated with signal management activities, safety and benefit-risk evaluation, management of potential safety issues, evaluation of databases for safety signals.

 

Specific responsibilities include:

  • Develop and implement signal detection strategy; Lead the signal management process and evaluate safety data and signals as part of ongoing pharmacovigilance activities.

  • Lead aggregate report management including strategy, review and finalization of safety reports such as DSURs and annual reports and demonstrates effective leadership skills with cross-functional partners to ensure aggregate reports are of high quality and submitted according to required timelines

  • Plans an executes literature surveillance

  • Support safety related activities for clinical trials including but limited to review and assessment of safety cases, writing narratives, and contributing author to protocols, ICFs, statistical analysis plans, safety content of Investigator Brochure and clinical study reports

  • Evaluate medical coding of safety data

  • Review standard design of tables, figures and listings for safety data from clinical studies

  • Support data safety monitoring board activities, as applicable

  • Provide safety content for regulatory filings, including review of the safety and benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation

  • Oversight of CRO and vendors responsible for operational activities related to safety

  • Participate in cross-functional clinical study management teams and program meetings

  • Develop and implement pharmacovigilance SOPs

  • Participate in the quality management system in Drug Safety including ensuring department standards are met, including developing SOPs, training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.

  • Ensures adherence to regulations, internal SOPs, and Drug Safety/PV agreements

 

Education / Experience / Skills:

  • M.D. degree required

  • Minimum of 8 years of pharmacovigilance experience with at least 5 years managing medical case review and signal detection in a biotech/pharmaceutical setting

  • Thorough knowledge of FDA and ICH guidelines

  • Proven experience working with within a cross-functional team environment

  • Knowledge of MedDRA terminology and its application

  • Thorough understanding of the drug development process and context applicable to safety surveillance activities

  • Ability to assimilate clinical data and through comprehensive analysis/review and able to make assessments

  • Ability to work in a fast-paced and collaborative environment

  • Strong written, verbal, technical and presentation skills

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