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AD Medical Review- Pharmacovigilance

Boston, Massachusetts


Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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AD Medical Review- Pharmacovigilance

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Job ID R0022882 Date posted 09/23/2020 Location Boston, Massachusetts

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda


  • Lead oversight of outsourced medical review of individual case safety reports for assigned products

  • Lead medical oversight for outsourced literature review for individual case safety reports

  • Provide medical expertise and guidance to the case management team


  • Lead the medical review, including oversight of outsourced medical review of seriousness, expectedness/listedness, causality, coding, and narratives of individual case safety reports for investigational and marketed products

  • Direct medical review including oversight of outsourced medical review of Literature review for individual case safety reports

  • Lead and direct the preparation, authoring, and approval of analysis of similar event reports

  • Lead and direct the medical input and guidance for ad-hoc queries for ICSRs

  • Lead and direct medical oversight and guidance to vendors performing case processing including required training

  • Lead and implement with alliance partners harmonization and industry standard medical review and case assessment standards

  • Perform other  duties as assigned by the Head of Global Medical Review to support PV activities


  • Qualified physician or PharmD

  • Critical thinking and analytical skills and ability to make high level decisions

  • Strong sense of planning and prioritization

  • Excellent oral and written communication skills including ability to present to large internal/external groups

  • Good level of computer literacy with Microsoft applications


  • Minimum 5 years pharmaceutical or health care related industry experience

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

  • Minimum 3 years experience in Pharmacovigilance including medical review of individual case safety reports


  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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Boston, MA

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Full time

Job ID R0022882

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