US-MA, Lead PV Scientist R0004899-MZ
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. Join us as a Lead PV Scientist in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products in conjunction with pharmacovigilance physicians * Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products * Represent pharmacovigilance department internally and externally at a global level and to function as an authoritative and professional member of relevant teams. * Lead signal detection/safety monitoring activities for pharmacovigilance operations. * Provide functional & therapeutic area expertise, thereby supporting junior pharmacovigilance scientist * Flexible outside of primary therapeutic area as directed by business and departmental need
Technically fully competent to perform all usual Senior Pharmacovigilance Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports * Liaise with other relevant functional areas both within and outside of global PV * Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required. * In depth knowledge and understanding of designated products/studies. * Provide support and oversight of pharmacovigilance operational activities within therapeutic area * Mentorship and guidance for junior/new pharmacovigilance scientists * Conduct project activities for designated developmental products: * Lead set up of safety procedures for complex developmental programmes o Contribute to development of safety exchange agreements for co-development projects
o Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents o Close knowledge of protocols to effectively respond to safety issues. o Providing investigator and monitor training on safety procedures o Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities. o Draft responses to regulatory/ethics safety questions o Assist with writing and maintenance of the Safety Monitoring Plan o Assist with set-up and running of DSMBs o Close working relationship with physicians, both technically and managerially o Perform ad hoc analyses e.g. in response to regulatory queries o Integral to Global Safety Teams and associated support o Other functions as directed by departmental and business needs * Any other tasks assigned by manager to assist in departmental activities
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Health care background or life science degree level qualification/Bachelors required; Advanced degree in scientific/medical field preferred * Excellent databases and coding skills including ability to perform advanced searches * In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis. * Critical thinking and decision making skills * Ability to review, analyse, interpret and present complex data to a high standard * Global player in a global PV organistion * Excellent communication and presentational skills * Good level of computer literacy * Excellent organisation skills and ability to prioritise
* Estimated 5-10 times per year including possible international travel.
WHAT TAKEDA CAN OFFER YOU:
Empowering Our People to Shine
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