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Associate Director, Aggregate reporting

Employer
Discover International
Location
Maidenhead, UK
Salary
Competitive
Closing date
Jul 16, 2019

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Job Role
Finance Director/Head of Finance
Sector
Finance
Contract Type
Permanent
Hours
Full Time
Job Description The Associate Director leads and manages the Aggregate Reports team, including forecasting budget/headcount; hiring, training, mentoring staff and is accountable for their performance. The Associate Director serves as subject matter expert on aggregate reporting safety requirements for PV Scientist Group, Safety. Manages the vendor responsible for aggregate reports, including contracts, budgets and ongoing project oversight. The Associate Director is responsible for leading initiatives for process improvement, and collaborating with the PV Sciences group, other Safety Staff and cross-functional groups to develop, implement and maintain processes that are compliant with global PV regulations, improve efficiency and lead to consistent work processes across assigned product groups taking into account cross-program practices. Qualifications
• Minimum 8- 10 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management. Minimum of 2 years managing direct reports
• Key skills: Understands, interprets, analyzes, 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 serves as a leader within the PV Scientist team. Strong organizational skills, including the ability to prioritize independently with minimal supervision. Ability to assess resource needs and adapt accordingly.
• 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.
• Management and authoring of aggregate data reports, including line personnel.
• Mentors PV Scientist staff.
• Represents and speaks to processes in cross-Safety and cross-functional forums.
• Successfully manages substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests performed by direct reports.
• Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information
• Subject Matter Expert in Pharmacovigilance and drug development; including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, 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. Education Bachelor's Degree in biologic or natural science Advanced degree (MSc, PhD, MPH, PharmD, etc.)

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