Drug Safety Associate

3 days ago

Pune, India Fusion Technology Solutions Full time

To write an effective drug safety associate job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety associate job description templates that you can modify and use.

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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