- Experience Level
- Experienced (non-manager)
On behalf of our client, a Dublin based pharmaceutical company, we are currently recruiting for a Pharmacovigilance Specialist for a growing PV Department. This is a permanent, full-time role.
The role of the Pharmacovigilance Specialist is an integral role for the company, ensuring the safety and wellbeing of the patients using the company’s medicinal products.
THE PHARMACOVIGILANCE SPECIALIST WILL:
• Support the Head of PV to ensure that pharmacovigilance system is compliant with applicable EU regulatory requirements, including but not limited to:
o Regulation (EU) No 726/2004 (as amended) or applicable national legislation
o Directive 2001/83/EC (as amended)
o The EU Guidelines on Good Pharmacovigilance Practices (GVP)
• Support the HEAD OF PV on:
o The Pharmacovigilance System Master File (PSMF)
o Functionally oversee global national pharmacovigilance contact persons where applicable
o Provide input to PV training and evaluation standards
o Maintain awareness of local PV Regulatory requirements and implementation plans
o Lifecycle maintenance of pV documents such as: PBERs, PSURs, RMPs, DSURs, PSMF updates and Annual Reports
• In relation to the medicinal product(s) concerned, support the Head of PV on:
o Global and local literature medicinal product surveillance
o Assists in the management of safety profile and emerging safety concerns
o 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
RMP’s are followed and tracked
o Prepares and manages preparation of global aggregate reports
o Assists on the preparation of Post‐Authorisation Safety Study (PASS) protocols (both in EEA and ex‐EEA where included in an RMP), manages PASS requests from
competent authorities, and the results of PASS, if applicable
o Manages and tracks on‐going/completed clinical trials and other studies conducted by company or partners
o Provide support into preparation of regulatory action in response to urgent safety concerns (e.g. variations, urgent safety restrictions and communications to patients and healthcare professionals)
o Drafts responses to competent authority requests relating to risk/benefit evaluation
o o 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: o Procedures (at every level) relevant to the pharmacovigilance system and fulfilment of pharmacovigilance related commitments
o SOPs, Project Instructions…
o Safety data exchange agreements
• Outputs from the Quality Management System (QMS), including not limited to: o Routine compliance metrics (PSUR/Individual Case Safety Report compliance/quality/completeness, safety variation implementation compliance, PV training compliance, Corrective Action and Preventative Action (CAPA)/deviation compliance)
o Updates on RMP/PASS commitments
o Notification of pharmacovigilance‐related audit schedules
o Notification of findings from pharmacovigilance‐related Audits and Inspections
o Contributing to CAPA plans arising from pharmacovigilance‐related audits and inspections
o Overseeing the quality of PV data (correctness and completeness) submitted to competent authorities
• Support the HEAD OF PV on preparation of:
o The validation status, validation failures and corrective actions and significant changes made in respect of the safety database
• Provide high quality medical information enquiry handling by managing inquiries in respect of company’s products. Track, reconcile and manage reporting of adverse events/product quality complaints/medical information inquiries.
• Be an active member of 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 / CROs
• Degree in Life Sciences.
• Minimum 2 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization.
• Understands and maintains strong working knowledge of PV global regulations and guidelines with PV operational knowledge.
• Working knowledge of MedDRA and Aris Global
If you are interested in applying for this role please call Linda on +353 1 2784671 or email Ldunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.