Pharmacovigilance Coordinator

4 weeks ago

India ProductLife Group Full time
Job Description

PLG is looking for a dedicated Data Officer- Coordinator to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.

Responsibilities:

- Data entry of vigilance cases in the relevant databases
- Preparation of initial email (in the context of follow up request), requests for clarification
- Submission of cases to the competent authorities
- Carrying out specific queries in the databases in order to draft reports
- Monitoring and downloading ICSRs in the national databases (Eudravigilance, MHRA portal)
- Quality control of vigilance cases
- Management of the generic or client specific email boxes as appropriate.
- Registration, triage, assignment and coordination for the processing of vigilance cases
- Client notifications
- Processing of vigilance cases received locally according to client specifications
- To provide support to the business unit on other pharmacovigilance activities, as required

Education and Experience

- Pharmacy Graduate/ Bachelors degree- scientific background
- Experience in coordinating workload and activity management.
- Min 1-2 year PV case management experience is a plus.
- Experience of communicating directly with clients
- Prior experience in a similar position is preferred
- Pharmaceutical background strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
- Knowledge of Safety databases (Safety Easy Argus)

Skills

- Effective communications skills
- Reliable
- Organized
- Punctual
- Safety database experience
- Previous experience performing triage and processing of post marketing cases

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