Associate Director, Pharmacovigilance & Epidemiology

The Associate Director, Pharmacovigilance & Epidemiology, under the guidance of the Director of Medical Safety Science, Risk Management, is responsible for liaising with  PVE Operations, managing clinical trial support activities, and accessing data for Aggregate Reports. The candidate should be recognized as an expert in Argus, pharmacovigilance, Pv regulations, and clinical trial support. The candidate should also be prepared to function as a key representative within PVE for the conduct and oversight of audits and inspections of systems and procedures for quality and compliance including authoring of responses to findings.

Roles and Responsibilities include:

• Ensure compliance with all reporting requirements to partners and regulators
• Liaise with PVE Operations regarding Argus for clinical trials management and submissions activities, and with  Standards and Compliance and Quality Assurance for inspection readiness
• Author and contribute to periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc)
• Support signal detection and signal evaluation activities
• Support development of core and local labels for products (e.g., CCDS, USPI, SmPC)
• Participate in preparing responses to safety-related requests from Health Authorities
• Provide safety content review of clinical protocols, CSRs, SAPs, and ICFs
• Liaise with PVE Operations, Data Systems, Epidemiology, and other cross functional teams
• Collaborate and contribute to the PVE Benefit-Risk team as appropriate
• Manage direct reports or vendors/contractors as needed

Experience, Skills, Knowledge:

• Excellent interpersonal and communication skills, both written and oral
• Safety database experience is required
• Understanding of medical terminology and the ability to summarize medical information is required
• Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
• Demonstrated success working both independently and in collaboration with others
• Understanding of safety database structures and familiarity with data retrieval tools is required
• Case processing experience is valued
• Knowledge of clinical trials activities and reporting requirements is required

Requirements:

• Health care professional degree (i.e. RN, PharmD) and 6+ years of drug safety experience in both clinical and post-marketing environment OR 7+ years of drug safety experience in both clinical and post-marketing environment and a BS degree in a health care or life science
• Previous people management experience
• Strong knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
• Strong knowledge of safety database (ARGUS), MedDRA, and WHO Drug
• Strong quality focus, with a good understanding of quality systems and compliance