Patient Safety Senior Medical Director

Vertex Pharmaceuticals LLC; Boston (MA); Sur place; USD 276 000 - 414 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Annual equity awards

Résumé du poste

Vertex Pharmaceuticals seeks a Patient Safety Senior Medical Director to lead safety and risk management for assigned products across pre- and post-approval. You will drive risk management activities, participate in regulatory engagements, and lead the clinical safety content for key documents.

The role requires MD/DO or equivalent with extensive experience in safety reviews, signal detection, and cross-functional collaboration in a matrix environment.

Qualifications

• MD/DO or equivalent medical degree required.
• 7+ years of experience in safety/pharmacovigilance or related field preferred.

Responsabilités

• Leads safety and risk management activities for assigned products across pre- and post-approval.
• Represents safety lead on cross-functional study and program teams.
• Reviews and provides medical input for safety reports and regulatory submissions.
• Oversees development ofRisk Management plans and labeling discussions.
• Guides staff on adverse event collection and evaluation from a medical perspective.

Connaissances

GCP & ICH

Benefit-Risk principles

Multi-tasking

Communication skills

Independent judgment

Matrix environment

General Medicine

Data interpretation

Safety data reviews

Formation

MD/DO or equivalent medical degree

7+ years experience

Description du poste

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.

Key Duties and Responsibilities

• 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

Knowledge and Skills

• 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 AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents

Education and Experience

• MD, DO or equivalent ex-US medical degree
• Typically requires 7 years of experience, or the equivalent combination of education and experience

#LI-JM1 #LI-Hybrid

Pay Range

$276,000 - $414,000

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Benefits

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance program