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Pharmacovigilance
Nagpur, Maharashtra
₹25,554.15 - ₹40,467.34 a month
Permanent, Fresher

Job details

₹25,554.15 - ₹40,467.34 a month
Paid sick time, Provident Fund, Flexible schedule
Permanent, Fresher
Nagpur, Maharashtra

Full job description

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 and IT skills

Job Types: Permanent, Fresher

Pay: ₹25,554.15 - ₹40,467.34 per month

Benefits:

  • Flexible schedule
  • Paid sick time
  • Provident Fund

Work Location: In person

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