Medical Director - Pharmacovigilance (PV), Global Medical Safety (remote)

Company: Biolife Plasma Services
Location: Cambridge
Posted on: February 20, 2021

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 Takeda'sand . 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 (PV), in our Global Medical Safety Team. Position is based virtually (remo.OBJECTIVE:-

• Support marketed products: Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s)
• Support Therapeutic Lead: Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needsACCOUNTABILITIES:-
  • Expectation of GSL role for marketed compound(s) 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, ----------- expertise in preparing regulatory responses to Pharmacovigilance Risk Assessment Committee (PRAC) and other health 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
  • 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, BEHAVIORAL COMPETENCIES AND SKILLS:
    • Qualified physician (License, e.g. GMC registered, preferred)
    • Minimum of 8 years of 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 applicationsWHAT 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-.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-No Phone Calls or Recruiters Please.#LI-JV1LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Biolife Plasma Services, Cambridge , Medical Director - Pharmacovigilance (PV), Global Medical Safety (remote), Healthcare , Cambridge, Massachusetts