Medical Advisor/Pharmacovigilance Scientist (2-7 yrs) Mumbai (Pharma Covigilance & Drug Safety)
3 point HRM
Mumbai, Maharashtra
Permanent
Full-time
30 days ago
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 SOPsQualifications 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 (ref:biojoby.com)