Senior Principal Pharmacovigilance Scientist, Gastrointestinal and Inflammation

About the position At reputed company, we are a reputed company-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 reputed company 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 reputed company 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.

Responsibilities

• Technically fully competent to reputed company reputed company usual Principal Pharmacovigilance Scientist/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 reputed company and reputed company 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.
• Provide support and reputed company of pharmacovigilance operational activities for designated compounds.
• Conduct project activities for designated developmental products.
• reputed company set up of safety procedures for reputed company 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.
• Participate in Global Safety Teams, coordinating reputed company aspects of signal detection/safety review activities.
• Draft responses to regulatory/ethics safety questions.
• reputed company reputed company analyses in response to regulatory queries.

Requirements

• Bachelor's degree required.
• Advanced degree or specific pharmacovigilance qualification preferred (MD, Ph.D., and PharmD).
• 6+ years of reputed company 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-reputed company regulatory authority requests (2 years).
• Apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and safety profile to reputed company risk/benefit analysis (risk management plan) (2 years).
• Utilize proficient communication skills with the ability to review, analyze, interpret and present reputed company 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 reputed company 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 reputed company data to a high standard.
• Advanced computer skills with the ability to work reputed company multiple systems; advanced skills in reputed company Office products (including Outlook, Word, and reputed company).

Benefits

• Development Opportunities / Career Growth and Expansion
• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community reputed company Programs and a company match of charitable contributions
• Family Planning Support and Family Leave
• Flexible Work Paths
• Tuition reimbursement

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