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Pharmacovigilance Coordinator (Data Officer)

Min Experience

1 years

Location

remote

JobType

full-time

About the job

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About the role

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 and AE forms Preparation of initial email (in the context of follow up request), requests for clarification 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 Processing of vigilance cases received locally according to client specifications Client notifications Submission of cases to the competent authorities (if required) Carrying out specific queries in the databases in order to draft reports To provide support to the business unit on other pharmacovigilance activities, as required Education and Experience Pharmacy Graduate/ Bachelor's 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 (desirable) Skills Effective communications skills Reliable Organized Punctual Safety database experience Previous experience performing triage and processing of post marketing cases Working Hours: Central Europe Time coverage (1.30-9.30 pm IST)

Skills

pharmacovigilance
data entry
case management
quality control
communication
safety database
regulatory