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Director, Signal Management

Company: Takeda
Location: Somerville
Posted on: June 17, 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 Director, Signal Management, in our Cambridge, Massachusetts office or virtually.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 Director, Signal Management, working on the GPSE team, you will be empowered to ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (e.g., with Global Regulatory Affairs, Data Sciences). - A typical day will include:POSITION OBJECTIVES:Ensures that Takeda Signal Management processes and activities are compliant with EU regulations and EU regulatory authority and inspectors' expectations.Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal GPSE stakeholders.Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.POSITION ACCOUNTABILITIES:Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company's products.Ensure patient safety for company's products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globeRepresent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information regarding status, issues, and/or challengesStrategize and align with the GSLs in developing data analysis strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategiesCreate visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific mattersProvide input to safety documents and reports to be submitted to regulatory authorities.Supports inspections and audits related to Signal Management and associated commitmentsLeads interactions with other GPSE functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained.Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.Leads training for GPSE and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.Leads interactions and oversight of signal management activities conducted by any vendor.Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained.Designs and delivers relevant training as appropriate.Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate.Conduct project activities for designated processes.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:Minimum Bachelor's degree plus 10+ years of relevant experience in drug safety/pharmacovigilance, or related fields in the pharmaceutical industriesGraduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) preferredExcellent communication and interpersonal skills and experience in mentoring othersAbility to review, analyze, interpret, and present complex data to a high standardGlobal player in a global PV organizationExcellent strategic decision-making and analytical skills - Strong leadership skills with excellent track recordComputer skills including proficiency in use of Microsoft Word, Excel & PowerPointStrong verbal, writing and organizational skills, including a good command of EnglishGood working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelinesIn depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysisDemonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)Experience with the preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approvalExperience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labelsTRAVEL REQUIREMENTS:Some domestic and international may be required on an infrequent basisAbsent 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: $ 160,000 to $ 229,000, 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda, Somerville , Director, Signal Management, Executive , Somerville, Massachusetts

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