Posted: Tuesday, May 9, 2017 1:59 AM
External Posting TitleAssociate Director, PV Scientist
Job DescriptionAs a leader in the PV Scientist Group, the Associate Director is responsible for the oversight and management of Pharmacovigilance activities for a group of products, including oversight of aggregate reporting for all products within the product group, overseeing signal management activities for the assigned group of products, oversight of management of responses to ad hoc regulatory responses, oversight of literature review/management for safety findings, and oversight of clinical trial safety activities for assigned products. In this role, the Associate Director may serve as the lead PV Scientist for a group of products as well as manage and mentor PV Scientists, Senior PV Scientists and PV Coordinators assigned to products within the Associate Director's designated product group. The Associate Director monitors resourcing for all assigned products and manages or reassigns tasks/projects across assigned programs and staff, as workload requires. The Associate Director is responsible for hiring, training, mentoring and managing staff within their PV Sciences product group. The Associate Director responsible for leading initiatives for process improvement, and collaborating with the PV Sciences group, other SABR 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.
* Direct supervision of Sr. PV Scientists, PV Scientists, and/or PV Coordinators. Including hiring, training, and mentoring of PV Scientist staff.
* Overseeing aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group
* Identifies process / procedural non:compliance, gaps or inefficiencies. Leads initiatives for process improvement; implements and maintains processes. Manages staff and corrective actions when non:compliance are identified. Serves as example for behaviors that lead to high quality outputs (i.e., quality checks, transparency, expert consultation, etc.)
* Monitors and manages resourcing for assigned products to ensure compliant, high:quality, timely deliverables.
* Serves as subject matter expert on relevant safety requirements, company policies / procedures related to Pharmacovigilance activities, as well as product and program knowledge.
LocationCambridge, MA, US
Job CategoryDrug Safety
QualificationsMinimum 6:8 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Minimum of 3 years managing direct reports.
* 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.
* 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
* Oversees substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests performed by direct reports. Oversees and mentors less experienced PV Scientist staff.
* 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
• Location: Boston, cambridge
• Post ID: 39111821 boston