Senior Principal Pharmacovigilance Scientist in Inflammation

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Principal Pharmacovigilance Scientist in the Inflammation Team where you will provide pharmacovigilance functional area expertise to project teams for assigned developmental and marketed products and be responsible for operational pharmacovigilance activities for assigned developmental and marketed products. You will represent pharmacovigilance, both regionally and globally as an authoritative and knowledgeable member of Global Clinical Development Teams (GCDTs) and similar, determined by the position's seniority/experience. You will also be involved in signal detection/safety monitoring activities for pharmacovigilance operations with a lead responsibility. As part of the GPSE Global Medical Safety team, you will report to the Senior Medical Director, GI and work with the broader safety cross-functional groups.

How you will contribute:

• 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 the 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 the development of safety exchange agreements for co-development projects.

• Review and provide functional area expertise for the 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 e.g. 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 audien