Patient Safety Senior Medical Director

General Summary

Job Description General

Summary:

The Patient Safety Senior Medical Director will provide leadership for all safety and risk management activities for assigned products, pre- and/or post-approval. This role will lead Risk Management activities, pre-, peri- and post-approval (as applicable) for assigned compound(s) and will provide relatively autonomous leadership of periodic (aggregate) safety report, signaling, labelling and DST activities for assigned compounds, as well as participate in individual case medical review.

This role will lead representation, as safety lead, on clinical teams/programs, regulatory filings and submissions and other intra and/or inter-departmental activities and initiatives, including process/SOP development, audits and inspections.

Represents department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert input regarding safety matters and issues.

Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed, demonstrating solid judgment.

Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.

Participates in the analysis of safety data from on‑going and completed clinical trials and its presentation in Clinical Study Reports.

Provides strategic leadership in the content for periodic reports (DSUR, PSUR) for assigned products.

Reviews and provides medical content, as needed, for key study‑related documents, e.g. IB, ICF, IDMC Charters.

Provides leadership in pre‑, peri‑ and post‑approval Risk Management activities and deliverables, including dRMP, RMPs and product safety labeling, as well as key regulatory engagements, such as Advisory Committee meetings, EU Pre‑submission meetings, and Pre‑NDA meetings.

Participates in departmental development activities including SOP and Work Instructions development.

Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective through leadership of Product Teams.

Provides timely and sound medical review of individual case safety reports from clinical trials or post‑marketing sources.

As directed by a Disease‑area Safety Head, perform due diligence from the perspective of Global Patient Safety for potential in‑licensed compounds.

Provides Global Patient Safety function in Partner /Affiliate agreements and interactions, as needed.

As directed by a Disease‑area Safety Head, serve as Chair of one or more Disease‑area Safety Team(s) for assigned products, assuming primary responsibility for the conduct and deliverables of the Teams.

Participates in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with Vertex signal detection practices.

Other activities as needed or as requested by GPS Management.

Solid knowledge of GCP, ICH and Global regulations.

Strong knowledge of current Benefit‑Risk principles.

Ability to multi‑task.

Solid written and oral communication skills to communicate highly complex ideas and interact/negotiate with senior leaders.

Solid independent judgment and decision‑making skills, including the identification and communication of relevant safety‑related issues or concerns to GPS Management in an appropriate and timely manner.

Sound ability to communicate effectively in a matrix environment.

Advanced knowledge of General Medicine.

Advanced experience in the evaluation and interpretation of data.

Advanced experience in safety reviews of…