Director, Patient Safety & Pharmacovigilance (PSP) Safety Physician

职位描述

Director, Safety & Pharmacovigilance (PSP) Safety Physician

POSITION OVERVIEW:

You will develop and ensure that strategic medical input relative to safety is incorporated into product development and lifecycle management as well as perform other advanced PSP activities for one or more products in the assigned therapeutic area.

You will provide strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to post marketing. You will ensure that signal detection, development of benefit-risk evaluation management plans, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner. You will also provide input on behalf of PSP into study-related activities and documentation, regulatory submissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects, and PV or other audits and inspections. You may act as the expert, go-to person regarding the safety profile of a product/compound or group of products/compounds. You will play a lead role within PSP by contributing to the ongoing and continuous improvement and advancing capabilities of the function.

EXAMPLE RESPONSIBILITIES:

• Accountable for the successful oversight and completion of a broad spectrum of PSP activities and deliverables for one or more products, compounds or indications, in compliance with established practices, policies, processes, and any regulatory or other requirements
• Advises other functions on short- and long-range PSP strategies, plans, resources and tactics 
• Performs or otherwise oversees safety reviews of clinical trial protocols, clinical study reports, informed consent forms, and other study related documents  
• Provides medical input on the PV activities for assigned products
• Contributes to and/or oversees the preparation of aggregate safety reports and risk management plans (RMPs)
• Conducts and/or oversees signal detection and evaluation activities for assigned product(s) as part of the continuous benefit-risk evaluation throughout the product(s) lifecycle
• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables
• Contributes to and/or oversees PSP activities and input related to regulatory filings (e.g., Biologics License Applications [BLAs], Investigational New Drug [IND] Applications), and responses to safety queries from third parties, such as regulatory agencies
• Participates on PSP and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and PSP functional area support in PV audits and inspections
• May serve as medical monitor for post-authorization safety studies
• Provides matrix management and leadership to project teams.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

BASIC QUALIFICATIONS

• MD/DO degree or equivalent with 4+ years of relevant experience

PREFERRED QUALIFICATIONS

• Completion of an accredited medical or surgical residency program
• Board certification is strongly preferred
• Experience in drug safety signal detection, benefit-risk evaluation and authoring drug safety risk management plans and aggregate safety reports is preferred

Knowledge & Other Requirements

• Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives
• Strong interpersonal skills and understanding of team dynamics
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees
• Strong negotiation and conflict resolution skills
• Strong coaching capabilities to mentor/develop staff
• When needed, ability to travel