ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.

Responsibilities

To perform 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

Bachelor s or Master s degrees in 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 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