Assist with the overall Clinical Safety and/or PV&DSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).
Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
- He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
- entry of safety data onto adverse event database(s) and tracking systems
- review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- write patient narratives
- code adverse events accurately using MedDRA
- determine expectedness/listedness against appropriate label
- identifies clinically significant information missing from initial reports and ensures its collection
- ensure case receives appropriate medical review
- prepare follow-up correspondence consulting the medical staff accordingly.
- ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
- reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
- provide independent QC of AE reports for other members of the group
- May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
- Maintain a strong understanding of Covance’s safety database conventions or client-specific database conventions, as appropriate.
- Participate in signal detection, trend and pattern recognition activities, as appropriate.
- Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.
- Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
- Work with Data Management or client on reconciliation of safety databases, if appropriate.
- Monitor workflow for assigned studies/programs to ensure all deadlines are met.
- Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data are provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
- Build and maintain good PV&DSS relationships across functional units.
- Demonstrate role-specific Competencies on a consistent basis.
- Demonstrate company Values on a consistent basis.
- Begin to prepare Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.
- Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
- Assist PV&DSS management to identify out of scope work.
- Actively participates in project team and client meetings and liaise with clients, where appropriate.
- Prepare and/or participate in client or regulatory audits.
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
- Assist with the set-up of, and the provision of data to Safety Committees/DSMBs.
- Assist in the co-ordination of endpoint committees, as required.
- Any other duties as assigned by management.
Drug Safety associates with a minimum a bachelor's degree in a Health Science Discipline (B.Pharm, M.Pharm, Nursing, Medicine or Dentistry-qualified HCP equivalent to Canadian HCP training) is required.
Drug Safety Associate with at least 6 months of PV experience with case processing and an understanding of the FDA, EU and Canadian Pharmacovigilance regulatory requirements and knowledge of Local ADR databases is preferred.
We encourage candidates with 1 to 6 years of drug safety case processing experience to apply and they should also be open to working in shift based environment