Posted in: Other in Chicago | Posted: |
Job Description
Purpose:
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and supports one or more psychiatry products as the PST Lead. Ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Responsibilities:
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analyses and interpretations to cross-functional teams
Effectively write, review and provide input on technical documents independently. Contribute to the strategy for periodic reports (PSUR’s, PADER’s etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing.
Responsible for implementing risk management strategies for assigned products
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)