Director, Drug Safety Physician, Medical Review

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

The Director, Medical Review supports Global Pharmacovigilance with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed product across all therapeutic areas.

• Responsible for performing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations.
• Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to queries.

How you will contribute:

• Perform and conduct oversight of global medical review of individual case safety reports for Takeda investigational and marketed products from all sources, including but not limited to the following:
  • seriousness criteria confirmation and expectedness/listedness assessment
  • review of the reporter’s causality and company causality assessment
  • event confirmation and coding as per convention,
  • analysis of similar events as required,
  • provide sound rationale in Company Comment regarding causality,
  • ensure due diligence in adequate follow-up, and timeliness of expedited reports
• Collaborate with other PSPV personnel from other functions (AE processors, safety scientists and Global Safety Leads) in evaluating the safety profile of Takeda products.
  • Establish with alliance partners harmonization and industry standard medical review and case assessment standards
  • Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to the queries
  • Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products
• Ensure compliance, consistency and timely medical review
  • Ensures complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames.
  • Partners with safety operations teams to ensure consistency of work practices and SOPs.

• Support inspections and audits, and Corrective and Preventive Actions (CAPA) related to medical review and case assessment
• Support (or may lead) initiatives or projects improving Medical Review activities and processes
• Mentor and train new and or junior colleagues
  • Work with the Head of Medical Safety Review to implement and augment onboarding and training processes
• Perform such other duties as requested by management

Minimum Requirements/Qualifications:

• Medical degree required or internationally recognized equivalent.
• USMLE/ECFMG/COMLEX-USA/FLEX preferred but not required.
• Minimum 7 years pharmaceutical or health care related industry experience
• Minimum 3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
• Minimum 5 years 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.
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
  • Demonstrate integrity
  • Work productively in a high pressure environment
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
• Good analytical/judgment/ critical thinking capabilities to understand/analyze/synthesize and communicate
• Attention to details, computer literacy, knowledge of safety database
• Take initiative in collaboration with management to problem solve and address operational issues or identify opportunities for improvements
• Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

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About Us

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.

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