Local Safety Officer
E-Group
Summary
ProductLife Group is looking for a Local Safety Officer to join our dynamic team and to contribute to the activities performed in the Hub.
Job description
Responsibilities
- 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
- 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
- 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
- Participate in audits / inspections and resulting action plan
Education and Experience
- Bachelor's degree in science/Industrial Biology/Chemistry Engineer
- Min 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
- Database experience preferred
- Process oriented
- Enjoys working with documentation
- Good computer skills
- Works well within a team
- Knowledge of medical terminology
- Organized
- Flexible
- Excellent communication skills in English
Requirements
- Bachelor's degree in science/Industrial Biology/Chemistry Engineer
- Min 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
- Strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
- Process oriented
- Enjoys working with documentation
- Good computer skills
- Works well within a team
- Knowledge of medical terminology
- Organized
- Flexible
- Excellent communication skills in English
Company overview
E-Group is a medical equipment manufacturing company specializing in the development and production of innovative medical devices and healthcare technologies. While specific details about the company's product portfolio are limited, as a medical equipment manufacturer, E-Group likely focuses on creating diagnostic, therapeutic, and monitoring devices that serve various healthcare applications. The company operates within the highly regulated medical device industry, adhering to strict quality standards and regulatory requirements to ensure patient safety and product efficacy. Medical equipment manufacturers like E-Group play a crucial role in advancing healthcare by providing healthcare professionals with the tools needed for accurate diagnosis, effective treatment, and improved patient outcomes. These companies typically invest significantly in research and development to create cutting-edge technologies that address unmet medical needs and improve healthcare delivery across different medical specialties.