Data Officers (Pharmacovigilance)

Data Officers (Pharmacovigilance)

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