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
Eastern 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 the 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 the resulting action plan
Education And Experience
- Bachelor s or Master s 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, and 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-oriented with good attention to detail
- Effective communication 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 works to timelines
- Safety database experience
