30/04 Swati Khemka
Associate at 3 point HRM

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Medical Advisor/Pharmacovigilance Scientist (2-7 yrs)

Mumbai Job Code: 24048

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

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