Job Purpose and Scope
Pharmacovigilance Associate to handle PV activities within the PV Compliance Team. The role includes line management responsibilities for the PV Compliance Team and quality control of the following activities:
- Daily Mailbox Monitoring: Review summary emails and tables, delegate requests appropriately, and follow up on high-priority items.
- Safety Variation Notifications: Ensure accurate recording and communication of all safety variations.
- Follow-up on Individual Case Safety Reports (ICSRs): Review weekly summaries and ensure follow-up actions are documented and communicated.
- Weekly Bulletin Screening: Confirm accuracy of screened information and initiate necessary actions.
- Issuing Safety Variations: Oversee monitoring, ensuring timely updates and follow-ups.
- Archiving Regulatory Approvals: Ensure archived documents are complete, up-to-date, and accessible.
- Screening Monthly Compliance Reports: Validate reports and resolve discrepancies.
- Quarterly Agreement Reconciliation: Review and document reconciliations in the tracker.
- Reviewing Quality Technical Agreements (QTAs) and Safety Data Exchange Agreements (SDEAs): Approve new or revised agreements, ensuring compliance and documentation.
- Updating Agreements: Confirm updates are accurate and complete during monthly meetings.
- Updating Risk Management Materials (RMMs): Ensure tracker updates are accurate for individual territories.
- Participation in QPPV Meetings: Ensure accurate updates and active participation.
- Management of PV Quality Management System (QMS): Oversee QMS activities and ensure completeness.
- Training Coordination: Ensure training sessions are conducted and the training tracker is updated.
- Support for Audits and Inspections: Provide necessary support during audits and inspections.
Accountabilities :
Management of the PV Quality Management System (QMS)
- Oversee the PV QMS, including the Quality Manual, Working Practices, and supporting documentation.
- Ensure documentation and procedures comply with European legislation, focusing on PV processes.
- Develop and draft processes, practices, and standard operating procedures in line with evolving European PV laws and guidelines.
- Represent PV systems during audits and inspections, providing support and implementing corrective and preventative actions.
Pharmacovigilance System Master File (PSMF) Preparation
- Maintain and update the PSMF to ensure compliance with regulatory requirements.
- Coordinate with the QPPV to document PV system processes, organizational structure, and safety data management in the PSMF.
Training
- Ensure adequate PV awareness and education for PV personnel.
- Support competency training for team members in collaboration with global and regional training coordinators.
Governance Board Meeting
- Coordinate Governance Board Meetings, prepare agendas, and track action points.
Other Responsibilities
- Manage the PV data repository, including access and training.
- Monitor designated PV activities and report compliance regularly to the QPPV.
Working Relationships
Internal
- Collaborate with PV, Regulatory Affairs, and Quality Assurance departments to ensure daily PV activities.
- Coordinate with local and global PV teams and Regulatory Persons for Pharmacovigilance (RPPs).
External
- Engage with healthcare professionals, patients, consumers, local competent authorities, and partners/distributors/service providers.
Knowledge and Experience
- Preferably holds a life science qualification (e.g., pharmacy, chemistry, biology) with at least three years of specific PV experience.
- Strong working knowledge of European and local PV legislation.
- Process-oriented with high attention to detail.
- Proficient in computer literacy.
- Excellent organizational skills, capable of managing diverse tasks and changing priorities.
- Strong interpersonal and communication skills.