Drug Safety Associate
1 week ago
Sample responsibilities for this position include:
Identify out of scope activities in conjunction with the MSS Functional Lead
Determining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
Reconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance
Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines
Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements
Perform post surveillance activities such as literature review and media monitoring
Reconcile activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPs
Responsible for keeping drug safety databases up to date
Support the Drug Safety Team in ensuring high standards are maintained and opportunities for improvement are identified
Act as record management coordinator for the Drug Safety Team
Job Types:
Full-time, Permanent
Salary:
From ₹387,607.20 per year
Benefits:
- Food provided
- Health insurance
- Paid sick time
Schedule:
- Day shift
- Morning shift
Supplemental pay types:
- Overtime pay
- Performance bonus
- Yearly bonus
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
Experience:
- total work: 1 year (preferred)
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