Work From Home Jobs Pune

Statistical Pharma

Pharmacovigilance Associate

Job Description 

Primary Responsibilities:

1. General Responsibilities and Regulatory Compliance:

  • Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
  • Monitor national pharmacovigilance legislation.
  • Ensure appropriate interpretation and implementation of national pharmacovigilance regulation for both

drugs and devices.

  • Responsible for liaising with the Ministry of Health (MoH)/national regulatory authority (RA), work with legal, quality, medical and regulatory on safety issues if necessary.
  • Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
  • Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
  • Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
  • Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.

Job Types: Full-time, Regular / Permanent, Fresher

Salary: ₹286,059.71 – ₹1,250,090.43 per year

Benefits:

  • Health insurance
  • Provident Fund
  • Work from home

Schedule:

  • Day shift
  • Morning shift
  • Rotational shift

Supplemental pay types:

  • Performance bonus
  • Yearly bonus

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