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Medical Director, Pharmacovigilance, GI

Company: Takeda
Location: Somerville
Posted on: June 16, 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 Takeda's Privacy Noticeand 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, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Pharmacovigilance, GI, in our Cambridge, Massachusetts office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.As a Medical Director, Pharmacovigilance, GI, working on the GPSE team, you will be empowered to support developmental programs, including both early and late stage development as required. - A typical day will include:POSITION OBJECTIVES: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 scientistsFlexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needsPOSITION ACCOUNTABILITIES: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 responsibilitiesIntimate 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 - programsResponsible 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 etcTraining and mentoring of Pharmacovigilance Physicians and SpecialistsPerform activities required to serve as Global PV physician:Review and oversight of safety data, both non-clinical and clinicalReview and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authoritiesInteractions with external experts and regulatory agencies and partner/co-development companiesReview of safety data and participate in dose escalation decisionsAuthorship and sign off of Safety Monitoring Plan/Risk Management PlanLead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulatorsDirect the set up of safety procedures and development of safety exchange agreements for co-development projectsMaintain professional knowledge and accreditation by active participation in continuing medical education activitiesEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:Qualified physician (Licence, e.g. GMC registered, preferred)Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicineKnowledge of principles of epidemiology and statistics.Critical thinking and analytical skills and ability to make high level decisionsExcellent oral and written communication skills including ability to present to large internal/external groupsGood level of computer literacy with Microsoft applicationsAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.Base 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 Colorado's 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 PlanTuition reimbursementCompany match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda, Somerville , Medical Director, Pharmacovigilance, GI, Executive , Somerville, Massachusetts

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