Pharmacovigilance Officer

PLG is looking for a dedicated PV Officer to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data. 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: HCP – Bachelor's or Master's degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, midwifery etc 2+ years' experience in pharmacovigilance Previous experience working to deadlines Client communications Minimum 2 years' experience working for service providers performing data entry and QC of cases Knowledge of US FDA PV regulations Good understanding of MS Word, MS Excel Pharmaceutical background – strong understanding of GCP, FDA and regulatory requirements related to drug safety. Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment Language: Excellent English language and grammar skills (written and verbal fluency) Spanish (desirable but not essential) 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