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The Contractor, Pharmacovigilance Scientist supports safety data analyses for investigational and/or marketed products in partnership with the Pharmacovigilance Sciences team and product Safety Physician. The Pharmacovigilance Scientist is expected to be equally effective in working collaboratively and independently. She/he will support activities such as signal management, aggregate safety reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions or clinical trial documents, as applicable. The Pharmacovigilance Scientist also supports process improvement initiatives, including updates to SOPs, WIs, and other documents.

Key Responsibilities:

Support signal management activities, as needed, in collaboration with the Pharmacovigilance Scientist team product Safety Physician.Support aggregate safety reports (e.g. DSURs, PADERs, PBRERs), including data analysis, report authoring, and quality checks.Support RMP updates and REMS reports as appropriate.Support ad hoc query responses and safety analyses for regulatory submissions or clinical trial documents, as needed.Support literature surveillance for marketed products and medicinal products under development, as applicable. Demonstrate knowledge and remain up to date to ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.).Contribute to process improvement initiatives and consistency of cross-product processes.Maintain inspection readiness.Perform other tasks as assigned or required.

Qualifications:

Minimum 2-3+ years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety serving in a PV Scientist or similar role.Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS)Demonstrated experience in analysis, and interpretation of medical and scientific data.Excellent communications skills.Demonstrated ability to work effectively in a cross-functional team environment as well as independently.Ability to apply clinical judgment to interpret case information.Knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations.Familiarity with case processing, expedited reporting rules, and safety database concepts.Strong knowledge/proficiency with Microsoft Office Suite and Argus Safety systems.

P1405180BOSJB_1738013234 To Apply for this Job Click Here