Manage safety data using analytical skills, by processing all types of individual case safety reports (ICSRs) and aggregated reports and summaries of data. Develop and maintain processes required for Pharmacovigilance Systems.
Key Responsibilities
- Contribute to receipt, tracking, monitoring and documentation of ICSRs
- Perform data entry and quality control of ICSRs within the case-handling process
- Contribute to exchange of ICSRs with internal and external sources, and to regulatory reporting
- Contribute to follow-up of ICSRs
- Support and participate in audits and inspections
- Contribute to management of GPV Operation mailboxes
Requirements
- University level qualification in biosciences or healthcare
- At least 1 years’ experience post-graduation in the pharmaceutical industry
- Thorough knowledge of regulatory Pharmacovigilance requirements, specially within the European Union and US
- Fluent in English
- Computer Literate
- Able to work effectively both independently and collaboratively across the organization
- Team player
- Delivery focused with ability to exercise judgment, make decisions, and take action to complete assignments
- Good attention to detail with high quality written outputs, with good organizational abilities, prioritization, and time management proficiencies.
- Demonstrated problem solving the ability to successfully execute in an environment under time and resource pressures whilst maintaining resilience
Benefits
- Private Health Insurance
- Pension Plan
- Paid Time Off
- Work From Home
- Training amp; Development