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Associate Director, Pharmacovigilance & Epi RM

United Kingdom - CambridgePharmacovigilance & EpidemiologyRegular

Job Description

Specific Responsibilities
•Signal detection and authorship of signal work-up documents in collaboration with a Medical Safety Science Medical Evaluation (MSS-ME) team member
•Authorship of Company Core Data Sheet (CCDS) sections and associated supporting documentation
•Authorship of aggregate safety reports (e.g. Periodic Safety Update Reports (PSURs))
•Authorship of risk management plans
•Authorship of responses to regulatory agency safety enquiries.
•Contributes to safety analyses in Regulatory submissions (e.g. Marketing Authorisation Application (MAAs), New Drug Application (NDAs))
•Reviews global literature for identification of potential safety concerns
•Performs safety review of clinical trial protocols, investigator’s brochures, study reports,informed consent forms, and other study related documents for assigned studies
•Reviews standard reference documents in collaboration with a MSS-ME team member
•Collaborates with partner companies on safety evaluation for co-licensed products with minimal supervision

Essential Duties and Job Functions
•Offers significant contributions to safety committee meeting discussions (internal or with partner companies)
•Responsible for presenting results and findings and discussing processes in formal settings with consideration of the impact on processes within and external to GLPS
•Participates on and may lead various cross-functional teams involving interaction with Gilead staff within and external to GLPS
•Leads multiple projects simultaneously with minimal supervision
•Leads the analysis and resolution of complex problems collaboratively with cross-functional staff
•May write drug safety SOPs and contribute to drug safety audits or inspections
•May manage direct reports with responsibility for employee performance evaluations
•Evaluates performance and task management of junior employees
•Acts as a mentor to junior employees
•Work is performed under minimal supervision following established procedures
•Establishes recognition within GLPS as an expert in pharmacovigilance
•Anticipates complex problems which may arise and resolves them in a collaborative manner
•Demonstrates independent thought and initiative in the preparation and completion of projects

Knowledge, Experience and Skills
•Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g., biology, chemistry or neuroscience) with demonstrated experience with the responsibilities, deliverables, and skills required for this level
•Significant experience in drug safety is preferred
•Excellent knowledge of pharmacovigilance regulations, aggregate safety reports, risk management plans, signal detection, clinical trials and clinical development
•Demonstrates proficiency in verbal and written communication, including Microsoft Office, Excel, Word, and PowerPoint
•Demonstrates excellent attention to detail, project management skills, teamwork and initiative; maintains meticulous attention to project deadlines
•Demonstrates ability to influence others at the same or more junior levels within the organization
•Demonstrates excellent interpersonal and communications skills and ensures that all customers are fully informed and knowledgeable of project activities and their status
•Demonstrates ability to assess complex data sets and understand the safety/medical implications
•Demonstrates understanding of observational studies used in pharmacoepidemiology