Associate Director, PV Sciences, Global Medical Safety Oncology

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OBJECTIVE:

Principal responsibilities include:

• Supports the Global Safety Lead (GSL) for assigned oncology pharmaceutical / biological / drug-device combined products.
• Responsible for safety surveillance, signal detection and risk management activities.
• Supports cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products.
• Represent pharmacovigilance, both regionally and globally, as an authoritative and knowledgeable member of Global Program Teams (GPTs) and subteams, commensurate with position’s seniority/experience.
• Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with the GSL, for assigned product(s).

ACCOUNTABILITIES:

• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.
• Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT).
• Coordinate and perform signal identification, evaluation and management activities for assigned products, ensuring communication of all safety information that may impact the benefit-risk profile of assigned products to senior management.
• Assist with or lead authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses.
• Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs.
• Liaise with colleagues in relevant functional areas within and outside of PSPV to gather and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).
• 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 PSPV in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.
• Assist with or lead the preparation and presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies such as the Takeda Safety Board. 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, manage the short timelines that can ensue.
• Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues.
• Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
• Demonstrate outstanding knowledge of local and global health authority requirements.
• Support PSPV in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.
• Train and mentor newly hired peers and incumbent PV Scientists.
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning.

EDUCATION,…