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About the Role
The Executive, Pharmacovigilance (PV) and Medical Information (MI) will support the management of PV and MI activities, ensuring compliance with regulatory requirements, company procedures, and industry standards. This role involves close collaboration with internal teams and external providers for processing, assessing, and reporting safety information, as well as providing accurate medical information responses. The ideal candidate is organized, detail-oriented, and an excellent communicator, prioritizing patient safety.
Responsibilities
- Support the day-to-day operation of the PV system in accordance with applicable regulations, guidelines, & company procedures.
- Oversee vendor processing of adverse events, special situation reports, and product complaints.
- Ensure PV documentation is maintained accurately, completely and in an inspection-ready state.
- Monitor PV email inboxes and ensure timely escalation and processing of safety information.
- Support vendor and Line Manager with pharmacovigilance related activities.
- Assist with safety data reconciliation activities with internal departments and external partners.
- Support due diligence activities for potential future mergers and acquisitions.
- Support integration activities following mergers and acquisitions.
- Contribute to the review of the PV system master file.
- Support vendor with responses to MI enquiries from healthcare professionals, patients, distributors, and other stakeholders.
- Collaborate with the vendor to support the development of standard response documents.
- Ensure scientific and MI provided to stakeholders is accurate, balanced, and evidence-based.
- Ensure all PV and MI activities are conducted in accordance with applicable regulations, GVP requirements, company procedures, and quality standards.
- Support the maintenance of PV and MI procedures, work instructions, forms, and controlled documentation.
- Participate in CAPA, deviation, and change control activities.
- Contribute to quality and compliance initiatives to support continuous improvement.
- Support PV agreements and partner compliance activities.
- Support compliance monitoring of vendors and service providers involved in PV and MI activities.
- Support inspection readiness activities, ensuring records and documentation are maintained and accessible.
- Assist with internal audits, partner audits, and regulatory inspections.
- Participate in the preparation, collation, and review of audit and inspection documentation.
Requirements
- Educated in a health care related or life science field or equivalent demonstrated experience is required.
- Experience in PV operations is essential.
- Demonstrated capabilities in PV/MI vendor and partner management.
- Knowledge of EU/UK GVP, ICH requirements with the ability to operationalise legislation into compliant PV and MI processes, vendor oversight, and audit readiness.
- Excellent teamwork and communication skills, with the ability to influence and partner effectively with cross-functional stakeholders.
Education Level
- Educated in a health care related or life science field or equivalent demonstrated experience