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Medical Director, Pharmacovigilance, Marketed Products, Global Medical Safety

Company: Takeda Pharmaceuticals
Location: Baton Rouge
Posted on: September 21, 2022

Job Description:

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre 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. Join us as a Medical Director, Pharmacovigilance in our Cambridge, Massachusetts office or this role can sit remotely.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.As a Medical Director, Pharmacovigilance working in the Medical Safety team, you will support developmental programs, including both early and late stage development as required. A typical day will include:OBJECTIVE:

  • Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.
  • Supporting Therapeutic Lead
  • Line management responsibilities for junior physicians and/or scientists
  • Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needsACCOUNTABILITIES:
    • Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
    • Company wide safety expert for his/her compound responsibilities
    • Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed.
    • Serving in a leadership capacity for complex and strategically important programs
    • Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc.
    • Training and mentoring of Pharmacovigilance Physicians and Specialists
    • Perform activities required to serve as Global PV physician:
    • Review and oversight of safety data, both non-clinical and clinical
    • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
    • Interactions with external experts and regulatory agencies and partner/co-development companies
    • Review of safety data and participate in dose escalation decisions
    • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
    • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
    • Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
    • Maintain professional knowledge and accreditation by active participation in continuing medical education activitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
      • Qualified physician (License, e.g. GMC registered, preferred)
      • Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development
      • 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
      • Knowledge of principles of epidemiology and statistics.
      • Critical thinking and analytical skills and ability to make high level decisions
      • Excellent oral and written communication skills including ability to present to large internal/external groups
      • Good level of computer literacy with Microsoft applicationsTRAVEL REQUIREMENTS:
        • Estimated 1-2 times per year including international travelBase Salary Range: $ 217,000 to $ 310,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.This posting is made in compliance with Colorados Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq.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 ProgramsEmpowering Our People to ShineLearn more at takedajobs.comTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.#LI-NS1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote

Keywords: Takeda Pharmaceuticals, Baton Rouge , Medical Director, Pharmacovigilance, Marketed Products, Global Medical Safety, Executive , Baton Rouge, Louisiana

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