Assoc Director, Drug Safety

Primary Responsibilities

As a leader in the Safety Surveillance and Aggregate Reports group of Global Safety Regulatory Sciences (GSRS), the Associate Director is accountable for the oversight and management of Pharmacovigilance activities for assigned 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 group.

The Associate Director is responsible for leading initiatives for process improvement, and collaborating with the PV Sciences group, other Safety 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.

Minimum 8- 10 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management. Minimum of 2 years managing direct reports

• Key skills: Understands, interprets, analyzes, and clearly presents sc

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.