Senior Principal or Principal Pharmacovigilance Scientist
Posted on Apr 6, 2021 by Takeda Pharmaceuticals
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 Senior Principal or a Principal Pharmacovigilance Scientist in our Cambridge, MA office.
Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products.
Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.
Represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar, commensurate with position's seniority/experience.
Closely involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility.
Provide functional & therapeutic area expertise, supporting less experienced colleagues and the safety effort more generally.
Flexible outside of primary therapeutic area as directed by business and departmental need.
Technically fully competent to perform all usual Principal Pharmacovigilance Scientist/Senior Pharmacovigilance Scientist workload, including case report QC, review, follow-up and reportability assessments and input into aggregate safety reports, with the flexibility of mindset this requires.
Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.
In depth knowledge and understanding of designated products/studies.
Expect close interaction and involvement with senior PV physicians.
Provide support and oversight of pharmacovigilance operational activities for designated compounds.
Conduct project activities for designated developmental products.
Lead set up of safety procedures for complex developmental programs.
Contribute to development of safety exchange agreements for co-development projects
Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
Close knowledge of protocols to effectively respond to safety issues
Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities.
Draft responses to regulatory/ethics safety questions
Close working relationship with physicians, both technically and managerially
Perform ad hoc analyses eg in response to regulatory queries
Integral to Global Safety Teams and associated support
Other functions as directed by departmental and business needs
Proficient in all communication skills, with the agility to respond to different audiences in a clear and concise manner. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and where ad hoc issues arise, the short timelines that can ensue.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
6+ years of related experience.
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, analyze, interpret and present complex data to a high standard.
Global player in a global PV organization.
Excellent communication and presentational skills.
Good level of computer literacy.
Excellent organization skills and ability to prioritize.
This job posting excludes CO applicants