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Pharmacovigilance officer incharge openings at Noida – Pharmazz India

Pharmazz India Pvt. Ltd. is hiring for ‘Pharmacovigilance officer incharge’

Location: Greater Noida (On-site)

Qualifications: M Pharmacy / B Pharma / BAMS/BHMS/PhD / Pharm D/BDS/ MDS

Experience: minimum of 5 – 10 Years of experience working in a pharmacovigilance and clinical.

JOB RESPONSIBILITIES

  • Perform validity assessment and product-event triage of ADE cases.
  • Write accurate and concise summaries that capture the key elements from these published reports.
  • Prepare for and participate in Pharmacovigilance audits and inspections and related activities. Preparation, execution, and reconciliation of Safety Data Exchange Agreement (SDEA)/Safety Data Exchange Letter (SDEL) with business partners
  • Preparation and/or review of Risk Management Plan (RMP) and Health Hazard Evaluation (HHE) Impart training to Pharmacovigilance personnel on SOPS, WPDs, regulations, guidelines, etc.
  • Preparation of case summaries and Concomitant medications for the respective trials from the assigned Project managers, medical review of safety concerns to the corresponding trial subjects, assisting in safety protocols as and when required.
  • Individual handling of PVG database like clinevo. Individual handling of regularity submission to DCGI & CDSCO.
  • Strong personal computer skills, including the Microsoft Office suite of products

Application Process: Interested candidates can share your Resume at [email protected]

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