% of Time Job Function and Description
20% Product management/oversight.
May act as a 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.
Supports an organizational structure that meets the evolving needs of Shire and the GDS department. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the SA&R Team Lead, Heads of Medical Safety and SA&R and the Qualified Persons for Pharmacovigilance, including the EEA QPPV.
30% Aggregate report production.
Responsible for the production of periodic and ad-hoc safety reporting for therapeutic team products, where Shire is the Global Safety Database holder. Creates, coordinates, prepares and completes 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 Global Safety Lead to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and uses Shire's EDMS system to provide quality control.
Safety Review Meetings and signal detection.
Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Shire 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.
20% 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. Education and Experience Requirements
Key Skills, Abilities, and Competencies
- Life Science Degree or Healthcare Professional.
- Post-graduate qualification in a relevant discipline preferred.
- Minimum of 5 years' experience in a pharmaceutical company preparing, writing, authoring and submitting periodic safety reports.
- Experience in the support of post marketing surveillance and reporting to Regulatory Authorities worldwide.
- Solid 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 aggregate safety reports, including ICH-compliant PBRERs and responses to ad hoc regulatory queries; significant experience in the mentoring, training and assessment of staff involved in the preparation of aggregate safety reports.
- 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.