Head of Global Pharmacovigilance and EEA QPPV
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Neg
- Start date
- 6 Dec 2022
- Closing date
- 12 Dec 2022
View more
- Discipline
- Clinical Research, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Head of Global Pharmacovigilance and EEA QPPV
On behalf of our client, a Dublin based pharmaceutical company, we are currently recruiting for a Head of Global Pharmacovigilance and EEA QPPV. There are hybrid and flexible options available.
The role of the Head of Global Pharmacovigilance and EEA QPPV is an integral role for the Company, ensuring the safety and well-being of the patients taking medicinal products.
THE HEAD OF GLOBAL PHARMACOVIGUNCE AND EEA QPPV will:
- The EEA Qualified Person for Pharmacovigilance (QPPV) shall ensure that the company pharmacovigilance system is compliant with applicable EU regulatory requirements, including but not limited to: 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) Act as Pharmacovigilance (PV) point of contact for competent authorities on a 24-hour basis and as a deputy contact point for PV inspections. Assume responsibility as the EEA QPPV with overall responsibility for the safety of the company's products.
KEY RESPONSIBILITIES:
- To provide guidance for the development of global Pharmacovigilance strategies. Provides oversight to the creation, assignment, implementation, and closure of CAPAs with PV association. Establish and ensure continuous improvement of global, regional, and local PV procedures. Ensures tracking tools (e.g., for local Periodic Safety Update Reports (PSI-JR), Risk Management Plans (RMP), Individual Case Safety Reports (ICSR) are accurately maintained. Maintains compliance oversight of PV activities undertaken and delivers month compliance report to upper Management. Supports negotiations with health authorities and supports the review and submission of responses to regulatory agency questions, PSURs and RMPs and local risk minimization tools as needed. Manages regional communication network; lead monthly calls with local officers, maintain lines of communication with stakeholders including regional/country officer's RA, QA, clinical, legal, and commercial partners. Assure oversight for the medical review of safety events to ensure accuracy, integrity, and completeness of safety information, and to ensure consistency of medical coding of safety data.
- Ensure the on-going evaluation of the overall safety profile for client products, working in partnership with the client's partners to bring potential safety issues to the attention of upper management and health authorities as appropriate. Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds.
QUALIFICATIONS:
- Degree in Science (MSg PhD, MD) with further qualification/certification in project management methodologies and/or change management. Minimum 10 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization. Understands and maintains strong working knowledge of PV global regulations and guidelines with an excellent PV operational knowledge. Knowledge of regulatory processes is an advantage. Experience of working with CROs, vendors, and relationship management preferred. For full job spec and details related to this role & company please email your CV to tdunne@thornshaw.com or call Tina or Linda at +353 1 2784701/087 6811990. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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