Overview of the Role
The pharmacovigilance officerplays a vital role in the collection, documentation and reporting of safety data. The pharmacovigilance officer leads activities that help to ensure patient safety.
Key Responsibilities:
Pharmacovigilance
- Work within the PV team to ensure collaboration, compliance and completion of pharmacovigilance activities in a timely manner.
- Identify and assess ICSRs for processing, determining appropriate prioritisation criteria, inputting them into the safety database and tracking systems and constructing a case narrative ensuring compliance with pharmacovigilance requirements and reporting timelines.
- Assess, record and process solicited data, ensuring compliance with pharmacovigilance requirements and reporting timelines.
- Determine and perform suitable follow-up to complete solicited or spontaneous ICSRs according to company guidelines and reporting requirements.
- Conduct expedited reporting in accordance with worldwide regulatory agencies and competent authority requirements and company guidelines, ensuring data is processed swiftly and appropriately within required timelines.
- Contribute to the review of cumulative safety data for signal management.
- Retrieve, assess, review and log literature search outputs.
- Liaise with key partners to draft and co-ordinate safety data exchange agreements to ensure both parties reach a timely and compliant agreement.
- Liaise with key partners and other stakeholders/third parties regarding safety data collection and data reconciliation.
- Contribute to all activities prior to, during, and resulting from external inspections and internal/external audits, including close-out activities.
- Contribute to and support resolution in any required corrective and preventative actions relating to pharmacovigilance.
- Contribute to the preparation and maintenance of the Pharmacovigilance System Master File where required. This will include collation and administration.
- Contribute to the preparation and review and update of standard operating systems and guidance documents relating to pharmacovigilance operations and clinical safety.
- Involvement with all day-to-day pharmacovigilance activities as required, including quality review.
- Contribute to the preparation and conduct of audits, both internally for the company and externally for and of clients.
- Ensure all communication received by pharmacovigilance from regulatory agencies (e.g., MHRA) is forwarded to senior team members so that they may be answered in a complete and timely manner and contribute to responses to communications as required.
Medical Information and Regulatory Affairs
- Provide pharmacovigilance support to the Medical Information and Regulatory Affairs functions as required.
Pay: €35,000.00-€40,000.00 per year
Benefits:
- Additional leave
- Company events
- Company pension
- Employee assistance program
- Flexitime
- On-site parking
- Private medical insurance
- Sick pay
- Work from home
Work Location: Hybrid remote in Longford, County Longford
