Pharmacovigilance Associate
3 days ago
- Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable)
- Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners
- Supports PV Clinical Specialists in tasks and projects as needed
- Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
- Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
- Acts as single point of contact with key stakeholders for safety related activities, identifies potential business gaps and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Drug Safety management
Job Type: Full-time
Pay: ₹25, ₹45,336.00 per month
Benefits:
- Internet reimbursement
Language:
- Hindi (Preferred)
Work Location: In person
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▷ (3 Days Left) Pharmacovigilance Associate
2 days ago
Satara, MH, IN Statistical Insights Full timeResponsible for review of investigational new drug safety reports INDSR and submission to FDA as applicable Responsible for negotiation and implementation of pharmacovigilance agreements PVA with business partners Supports PV Clinical Specialists in tasks and projects as needed Responsible for identifying and developing training documents i e SOPs for the...
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Drug Safety Associate
2 days ago
Satara, India Fusion Technology Solutions Full time**Responsibilities**: - Collect and process adverse event reports from clinical trials and post-marketing sources - Perform case triage, data entry, and quality checks in safety databases - Assist in preparation of regulatory reports (e.g., CIOMS, MedWatch) - Conduct literature screening for safety data - Ensure compliance with global pharmacovigilance...
