Data Officers (Pharmacovigilance) ProductLife Group

2.0 - 4.0 years

0 Lacs

, India

On-site

ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub. You will be required to work Easter USA Time Zone. Responsibilities: To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required Management of the generic or client specific email boxes as appropriate. Registration, triage, assignment and coordination for the processing of vigilance cases Follow-up requests with local reporters Responding to queries from client and reporters To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients Support/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as needed To participate in audits / inspections and resulting action plan Education and Experience: Bachelors or Masters degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience 2+ years experience in pharmacovigilance working for service providers performing data entry and QC of cases Previous experience working to deadlines. Client communications Knowledge of US and EU PV regulations 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 Skills: Excellent organizational and interpersonal skills Ability to work well within a team Excellent time management skills Accountability and autonomy with assigned tasks Process orientated with good attention to detail Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team. Flexibility and adaptability to handle a dynamic workload Works well under pressure and working to timelines Safety database experience Show more Show less

Posted 1 week ago

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