Senior Principal Pharmacovigilance Scientist, Gastrointestinal and Inflammation

About the position Responsibilities • 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. • 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. • 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. • Participate in Global Safety Teams, coordinating all aspects of signal detection/safety review activities. • Draft responses to regulatory/ethics safety questions. • Perform ad hoc 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 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). 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 Outreach Programs and a company match of charitable contributions • Family Planning Support and Family Leave • Flexible Work Paths • Tuition reimbursement Apply tot his job Apply To this Job