Pharmacovigilance
2 months ago
**Duties & Responsibilities**:
1. Establishment and Maintenance of the Clients’ Pharmacovigilance system for the products (PSMF);
2. Have an overview of medicinal product safety profiles and any emerging safety concerns, if possible;
3. Maintain awareness of Pharmacovigilance regulatory requirements and developments; 4. Identify, collect and report adverse events (ADRs, SAEs, SARs, SUSARs);
5. Ensure the conduct of pharmacovigilance activities and the submission of all pharmacovigilance-related documents (e.g. ISCRS, SUSARs, DSURs RMPs) is in accordance with the legal requirements and GVP;
6. Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);
7. Read and acknowledge all necessary Company standard operating procedures (SOPs) and customer SOPs as required;
8. Creation and maintenance of pharmacovigilance agreements. Maintain a local register of all incoming PV related information and all correspondence in relation to Pharmacovigilance activities with agencies and customers based on signed agreements; 9. Perform other duties as assigned.
- **Qualifications and Experience**:_
1. Minimum Life Science Degree
2. Knowledge and familiarity with clinical trials
3. Excellent communication skills
**Job Types**: Full-time, Permanent, Fresher
Pay: ₹28,842.24 - ₹50,538.49 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Monday to Friday
Supplemental Pay:
- Performance bonus
- Yearly bonus
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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