Responsible for working collaboratively with the VP, PVRM to assess, track and document the ongoing benefit-risk profile of all products in development and marketing products. This includes contributing the safety sections of numerous aggregate reports (e.g., DSUR, PBRER, ASR), coordinating Safety Review Team (SRT) and Executive Safety Review Committee (ESRC) meetings, contributing to signal detection activities, and clinical development and product registration activities.
30%-Safety Review Team and Executive Safety Review Committee meetings, and Signal Detection Activities.
Oversee or is responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Wave products via established signal detection methodology and tools. Evaluate signals promptly in signal detection reports and ad-hoc responses to regulatory authorities.
Responsible for efficiently planning Internal Safety Review Committee and Safety Review Team (SRT) meetings, ensuring that stakeholders provide input from their respective areas of responsibility.
Contribute to safety sections of Risk Management Plans (RMPs), if needed.
30%-Support for investigational products and registration activities.
Effectively collaborate with stakeholders outside of GDS. Represent GDS department in cross-functional clinical programs and registrational activities and provide GDS support for clinical developmental programs.
20%- Aggregate report production.
Oversees or is responsible for coordinating and contributing to the production of periodic and ad-hoc safety reporting for therapeutic team products. Creates safety content and coordinates, with Global Regulatory Affairs and Medical Writing, the completion of aggregate reports (e.g. PBRER, DSUR, PADER, as well as ad hoc queries or reports) for submission to regulatory agencies around the world. Collaborates with the Vice-President PVRM or Designee to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the safety sections of relevant final document, and providing an overall review.
May act as a line manager or mentor to PV Scientists, or as a manager for a product or group of products. Oversees and assumes responsibility for assigned therapeutic products and PV activities through the lifecycle of the product. May include review of compliance in PV function and/or working directly with PV compliance staff.
•Life Science Degree or Healthcare Professional.
•Post-graduate qualification in a relevant discipline preferred.
•Minimum of 5 years previous experience working in a global pharmaceutical Pharmacovigilance Department
•Supervisory experience preferred
•Experience in the support of development products and reporting to Regulatory Authorities worldwide (post marketing surveillance preferred).
•Strong understanding of the clinical development and regulatory process.
•Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting.
•Competence in conducting safety data reviews for investigational and/or post marketed products.
•High level of expertise and experience in the preparation of safety sections of aggregate safety reports, including ICH-compliant PBRERs, DSURs and responses to ad hoc regulatory queries.
•Experience with MedDRA and drug coding reviews.
•Ability to contribute to and review standard operating procedures and other process-related documents.
•Excellent communication, collaboration and networking skills.
•Strong understanding of the interface between Pharmacovigilance and external departments.
•Ability to influence others within a matrix environment.
•Must be able to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
•Ability to work independently, take initiative and complete tasks to deadlines.
•Forward-planning and proactive.
•Support global decision-making and direction setting, including devising of future strategy and the management of complex tasks.
•May be required to travel domestically and internationally to other Wave sites and CROs or to external meetings (e.g., Investigator Meeting) (<10%)
Reports directly to Vice-President, PVRM. May have other accountabilities to senior stakeholders and/or customers. Interacts across multiple functions and geographic locations and supports senior levels of the organization. Particularly important relationships are with Global Clinical Development, Global Regulatory Affairs, Global Medical Affairs, Medical Writing, and Non-Clinical Development. Key external contacts include regulatory agencies, contract research organizations and vendors. Must have the ability to form partnerships with key stakeholders that address the strategic and operational needs of Wave. Represents the department in cross functional initiatives.