Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Director, Head of Medical Review in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver _Better Health and a Brighter Future_ to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES:
The Senior Director, Head of Medical Review
- Supports Global PSPV with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed products across all therapeutic areas.
- 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.
- Leads and manages global medical review and provide medical oversight for outsourced medical review activities.
- Ensures medical assessment of individual case safety reports meets highest standards and processes and activities are compliant with ICH, FDA, EMA, MHRA regulations.
- Provides guidance and leadership in harmonization of medical assessment of LOCs originated cases.
- Manages a team of medical review physicians and oversees vendors providing staff performing medical review services.
- Ensures that all medical reviewers are adequately trained to perform medical review of the ICSRs in the Global Safety Database as per company SOPs and guidelines.
POSITION ACCOUNTABILITIES:
- 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.
- Perform such other duties as requested by management.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- 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.
This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at takedajobs.com
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