Job Description

• At Client, 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 lifechanging therapies to patients worldwide.
• Join Client 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 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.

Minimum Requirements/Qualifications:

• Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, Ph.D., and PharmD).
• 6+ years of related experience required.
• Prior experience must include: Conducting safety signal detection, assessment, and management from various sources including medical scientific literature and global safety database (2 years);performing the medical assessment of the individual case and aggregate safety reports for product safety profile and addressing safety -related regulatory authority requests (2 years);apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to perform risk/benefit analysis (risk management plan) (2 years);utilize proficient communication skills with the ability to review, analyze, interpret and present complex safety data to a high standard during internal and global cross-functional collaborations for patient safety (2 years).
• Excellent databases skills and detailed understanding of MedDRA codes including the 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.
• Advanced computer skills with the ability to work within multiple systems;advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
• Global player in a global PV organization.

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