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AD Medical Review- Pharmacovigilance

Boston, Massachusetts

Overview

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.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

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

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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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

OBJECTIVE: 

  • 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

ACCOUNTABILITIES: 

  • 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • 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

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):

  • 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

WHAT TAKEDA CAN OFFER YOU:

  • 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

Empowering Our People to Shine

Learn more at takedajobs.com.

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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022882

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