The Pharmacovigilance Specialist will ensure the safety and well-being of patients taking medicinal products. Our client is looking for an and enthusiastic PV professional to join their growing Dublin based operations and PV Dublin team.
The PV Specialist will support the Head of PV to ensure that the pharmacovigilance system is compliant with applicable EU regulatory requirements;
- Regulation (EU) No 726/2004 (as amended) or applicable national legislation
- Directive 2001/83/EC (as amended)
- The EU Guidelines on Good Pharmacovigilance Practices (GVP)
Support the Head of PV on;
- The Pharmacovigilance System Master (PSMF)
- Functionally oversee global national pharmacovigilance contact persons where applicable.
- Provide input to PV training and evaluation standards.
- Maintain awareness of local PV Regulatory requirements and implementations plans.
- Lifecycle maintenance of PV documents such as PBER’s, PSUR’s, DSUR'S, PSMF updates and Annual Reports.
In relation to the medicinal product(s) concerned support the Head of PV on:
- Global and local literature medicinal product surveillance.
- Assists in the management of safety profile and emerging safety concerns.
- Prepares and assists in the management of Risk Management Plans project timelines.
- Ensure all risk management documents are prepared according to regulatory requirements, Facilitate review and sign-off.
- Ensure all regulatory commitments in commitments in RMP’s are followed and tracked.
- Prepares and manages preparations of global aggregate reports
- Assists in the preparation of Post-Authorisation Safety Study (PASS) protocols (both in EEA and ex-EEA were included in an RMP), manages
- PASS requests from competent authorities, and the results of PASS if applicable.
- Manages and tracks on-going/completed clinical trials and other studies conducted.
- Provide support into the preparation of regulatory action in response to urgent safety concerns (e.g. variations, urgent safety restrictions and communications to patients and healthcare professionals)
- Draft responses to competent authority requests relating to risk/benefit evaluation.
- Support provision of any other information relevant to risk/benefit evaluation to competent authority requests.
Support the Head of PV on ongoing or ad-hoc preparation of:
- Procedures (at every level) relevant to the pharmacovigilance system and fulfilment of pharmacovigilance relate commitments.
- SOP’s, Project instructions
- Safety data exchange agreements.
Outputs from the Quality Management Systems (QMS):
- Routine compliance metrics (PRUR/individual Case Safety Report) compliance /quality/ completeness, safety variation implementation compliance, PV training compliance, Corrective Action and Preventative Action (CAPA) / deviation compliance)
- Updates on RMP/PASS Commitments.
- Notifications of pharmacovigilance-related audit schedules.
- Notification of finding from pharmacovigilance -related Audits and Inspections.
- Contributing to CAPA plans arising from pharmacovigilance -related Audits and Inspections.
- Overseeing the quality of PV data (correctness and completeness) submitted to competent authorities.
Support the Head of PV on the preparation of;
- The validation status, validation failures and corrective actions and significant change made in respect of the safety database.
- Provide high-quality medical information enquiry handling by managing inquiries in respect of products. Track, reconcile and manage to report of adverse events/product quality complaints/ medical information inquiries.
- Be an active member of a global communication network; participate in monthly calls with local officers, maintain lines of communication with stakeholders including Regional/Country Officers, Medical Affairs, Medical information, Regulatory Affairs, Quality Assurance, Clinical, Legal, Marketing and Commercial partners.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to establish working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds.
- Effective liaison with external service providers / CRO.
- Degree in Life Sciences.
- Minimum 2 years Safety / Pharmacovigilance experience in Biotech, Pharma or Clinical Research organisation.
- Understands and maintains a strong working knowledge of PV global regulations and guidelines with PV operational knowledge.
- Working knowledge of MedDRA and Aris Global.
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