Responsibilities for pharmacovigilance scientist

- Act as core member for assigned products

- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate

- Provide complete PVRM product life-cycle support for assigned product(s)

- Serve as Pharmacovigilance resource to clinical and post-marketing cross functional teams

- Collaborate with clinical and post-marketing teams to foster communication of potential safety concerns

- Participate in the development of protocols, annual updates to the compound-specific safety reference documents (Investigator's Brochure, core safety information, etc), contribute and review Informed Consent Forms (ICF), ensure safety oversight in cooperation/leadership of the clinical trial medical team, represent PVRM in SAE reconciliation, final CSR narrative writing/review and contribute to the review of the final clinical safety report (CSR)

- Perform study-start activities, as necessary

- Acts as primary author/reviewer for assigned product aggregate periodic reports such as the DSUR, PADER, PBRER and others

- Perform on-going individual case quality review of representing company review in accordance with study Safety Management Plans, Safety exchange agreements and Merrimack SOPs

Qualifications for pharmacovigilance scientist

- Knowledge and experience in infectious diseases and/or vaccines is preferred

- Ability to effectively present to cross-functional teams is required. Drug & Product Safety Science

- Ability to effectively present to cross-functional teams is required

- Provide clinical, regulatory and technical pharmacovigilance expertise to DS&E medical function & DS&E leadership

- Lead the preparation of aggregate safety reports for newly launched Novartis products to meet regulatory requirements

- Alert the Medical Safety Physicians to potential safety issues recognized through single case medical review or aggregated data sets

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.