An internationally known biotechnology company has an opening for an Associate Director, Aggregate Reporting job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. The Associate Director Aggregate Reports will be in charge of establishing and leading a team of PV Scientists responsible for aggregate reports for investigational and post-marketing products (i.e., DSURs, PBRERs, RMPs).
- Lead and manage the Aggregate Reports team, including forecasting budget/headcount; hiring, training, mentoring staff.
- Serves as subject matter expert on aggregate reporting safety requirements for PV Scientist Group, SABR and cross-functionally.
- Establish, improves and/or monitor aggregate report processes and templates, including working cross-functionally to ensure global compliance with aggregate report writing and submission. Oversees and leads process improvements.
- Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Mentors others to develop these skills and provides oversight on deliverables representing this data.
- Oversees management and authoring of aggregate data reports. Oversees and mentors less experienced PV Scientist staff. Represents and speaks to these processes in cross-SABR and cross-functional forums.
- Subject Matter Expert in aggregate safety reports; including knowledge of applicable safety regulations.
- Includes knowledge of case processing, and safety database concepts. Demonstrates ability to mentor others and lead PV Scientists and SABR in decision making impacted by PV and drug development requirements.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems
- Strong organizational skills, including the ability to prioritize independently with minimal supervision. Ability to assess resource needs and adapt accordingly.
- Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information.
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues. Fosters collaborative relationships and models expected team behaviour.
Skills and Requirements:
- Minimum 8 years Pharmacovigilance experience, including management experience.
- Minimum 3 years’ experience with aggregate safety reports (DSURs, PBRERs, RMPs).
- Bachelor's Degree in biologic or natural science; or health case discipline
- Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
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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.