Senior Director, Head of Medical Review

BioSpace · Boston, MA · 3 wk ago

Healthcare$212k–$333k/yrFull-time

About the role

The Senior Director, Head of Medical Review will support Global PSPV with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed products across all therapeutic areas. They will be responsible for overseeing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations.

Responsibilities

Provide strategic leadership and oversight for medical review and case assessment activities.
Accountable for developing, authoring, maintaining, & approving procedural documents, associated templates/forms, training materials and other toolkits.
Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company’s products.
Ensure effective communication with both internal and external stakeholders and management on individual case safety assessment related issues and prompt response to the queries.
Responsible for liaising and driving collaboration with other stakeholders (peer function, cross-functions, quality) on medical review and case assessment activities, working closely with LOCs/DSOs; PSPV Operations, PSPV Medical Safety, and interface with Vendor Safety.
Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products.
Responsible for leading and conducting process impact assessments in response to changes in regulatory requirements identified through Takeda’s regulatory intelligence activities, and for implementing the appropriate changes to ensure compliance with the new regulatory requirements.
Responsible for leading or supporting initiatives or projects improving Medical Review activities and processes.
Support inspections and audits related to medical review and case assessment, and develop and implement Corrective and Preventive Actions (CAPA).
Responsible for keeping abreast of best practices, including industry trends, technological developments, and vendor landscape, etc. to identify potential use cases.
Ensure staff and vendor performance meets established KPls on quality and timeliness of performing medical review activities.
Review safety sections of clinical trial protocols, investigator brochures, and informed consents for selected drug development programs.

Requirements

Medical degree required or internationally recognized equivalent.

USMLE/ECFMG/COMLEX-USA/FLEX preferred but not required.

15+ years of pharmaceutical or health care related industry experience.

3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine.

15+ experience in Pharmacovigilance including medical review of individual case safety reports.

Good working knowledge of US, EU, MHRA drug safety regulations, CIOMS and ICH guidelines.

Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels.

Experience in people leadership, managing matrix teams, and coordinating collaboration with cross-functional teams.

Strong strategic thinking, planning, execution, and communication skills.

Global/international experience required, including the ability to collaborate with colleagues and staff in other locations.

Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development.

Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Qualifications