Senior Principal Pharmacovigilance Scientist in Inflammation

This a Full Remote job, the offer is available from: Idaho (USA) Job Title: Senior Principal Pharmacovigilance Scientist in Inflammation Location: Cambridge, MA 02139 - Remote Duration: 09 Months Remote – 8 AM to 5 PM About the role:

• At Client, 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 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 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.

How you will contribute:

• 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, with the
• flexibility of reputed company this requires.
• 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, with the advanced communication skills this requires.
• In-depth knowledge and understanding of designated products/studies.
• Expect reputed company interaction and involvement with senior PV physicians.
• 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.
• reputed company knowledge of protocols to effectively respond to safety issues.
• Participate in Global Safety Teams, coordinating reputed company aspects of signal detection/safety review activities.
• Draft responses to regulatory/ethics safety questions.
• reputed company working relationship with physicians, both technically and managerially.
• reputed company reputed company 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 reputed company communication skills, with the agility to respond to different audiences in a clear and concise manner.
• Where acting as the GSL can expect to reputed company presentations to Safety Board, with the detailed preparatory work this implies and, where reputed company 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 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)
• Global player in a global PV organization.

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