A leading, global biotechnology company is seeking a Safety Analytics and Reporting Lead to join their team in the UK. The company boasts an extensive and innovative portfolio and employs over 20,000 people all over the world. This is a contract role based in South East England.
Role and Responsibilities:
- Responsible for ensuring high quality of aggregate report production, Safety Review meeting coordination, signal detection activities, and clinical development and product registrational activities.
- Supports the Safety Analytics & Reporting Team Lead to ensure that their responsibilities as SA&R Lead are in accordance with global regulations and in collaboration with the Global Safety Leads physicians and other key PVRM and R&D stakeholders.
- 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 the company 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.
Aggregate report production
- Responsible for the production of periodic and ad-hoc safety reporting for therapeutic team products, where the company 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 the company'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 company 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.
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:
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.