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Pharmacovigilance Scientist Job
High Wycombe, Buckinghamshire
PEGlobal are currently seeking a PVER Scientist on behalf of their multinational pharmaceutical client. There is a 12 month contract on offer in the Buckinghamshire area.
POSITION SUMMARY: The Sr. Scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents.
PRINCIPAL RESPONSIBILITIES: • Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate • Collaborate with on strategy development • Initiate/Conduct/Oversee searches of internal and external databases • Perform and/or lead aggregate safety analysis and case level review • Author, contribute, and coordinate the preparation of core safety deliverables • Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met • Partner with vendor to develop reports/deliverables • Participate in cross-functional training of relevant stakeholders • Ability to understand nature of adverse drug reactions and complex associations • High level of flexibility and ability to (re)prioritize work of oneself and others • Ability to work across multiple functions and therapeutic areas • Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance
EDUCATION & EXPERIENCE REQUIREMENTS: • Bachelor’s Degree in Health or Biomedical Science (6-8 years industry experience or equivalent) • Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent) • Clinical/Medical writing or PV experience preferred • Strong English verbal and written communication skills • Scientific Skillset: Comprehensive Analytic and Conceptual Skills • Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines)