Drug Safety Associate

7 days ago


Wagholi Pune Maharashtra, India Fusion Market Research Full time

**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

**Salary**: ₹15,000.00 - ₹28,000.00 per month

**Benefits**:

- Flexible schedule
- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wagholi, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Higher Secondary(12th Pass) (preferred)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 8446600737


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