Pharmacovigilance Operations - Scientist

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.

PV  Operations - Scientist
Reports to the Head of Pharmacovigilance



Reporting to the Head of Pharmacovigilance, the PV Operations-Scientist role will lead and support pharmacovigilance and risk management activities for Leap clinical development programs in compliance with regulatory guidelines. This individual will support the development and implementation of signal management through contributions to clinical deliverables and activities

Specific responsibilities include:

  • Conducts all tasks in accordance with applicable Company Policies, Guidelines, Quality Documents, Standard Operating Procedures (SOPs), Working Instructions (WIs), and other Guidance and Standards, as well as current Good Clinical Practice (ICH-GCP) and applicable national regulations

  • Support the overseeing of PV/safety vendors

  • Support PV intake processes globally including but not limited to interfaces and shared processes with PV Clinical Development, Regulatory Affairs, Quality Assurance, Legal, etc.

  • Oversee and support PV intake mailboxes and communications of Individual Case Safety Reports (ICSRs).

  • Support PV's process for PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) including direct discussions with vendors/partners, creation, and maintenance of the agreements.

  • Support and oversee PV safety data reconciliations.

  • Support PV process for safety-related medical inquiries.

  • Support inspection readiness activities and participate in regulatory inspections.

  • Support the Head of Pharmacovigilance and Quality Management with developing and implementing appropriate PV processes and systems.

  • Ensure PV central and site file documentation is appropriately tracked and filed, e.g. TMF. Ensure that documentation complies with ICH/GCP and project specific requirements.

  • Reconcile and inventory PV study documentation periodically and for archiving at study close-out.

  • Supports PV activities including taking meeting minutes/providing agendas to the clinical team, tracking PV study trackers.

  • The PV  Operations-Scientist is responsible for supporting the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.

  • The PV Operations-Scientist also support cross-functional teams on safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the PV Scientist is critical supporting products in clinical trials and continue to maintain good standing with countries where studies are ongoing to ensure PV quality surveillance.

  • Administratively Support the signal management process (ie, signal detection, signal tracking, signal documentation, facilitating meetings decisions regarding signals and safety risk, etc.) for assigned product. 

  • Collaborates with Head of PV and other Clinical MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.

  • Support the ad hoc safety questions by internal and external stakeholders.

  • Support and participate in Safety Review Team meetings

  • Perform other clinical data analysis as needed and requested by the Head of PV and the Chief Medical Officer.

Education / Experience / Skills:

  • Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required.

  • Master’s or Doctorate level degree in health care related profession preferred, but not essential.

  • Minimum of 7 years of experience in drug safety/pharmacovigilance in a pharmaceutical industry setting or the equivalent. Small biotech experience is preferred, but not essential.

  • Global pharmacovigilance PV Operations experience with products in development and post market.

  • Safety signal detection and aggregate reporting experience.

  • Knowledge of FDA and EU regulations and ICH guidelines.

  • Strong analytical and problem-solving skills with attention to both strategy and detail.

  • Strong verbal, written technical communication and presentation skills.

  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within the organization.

  • Proven ability to work within a cross-functional team.