Recruitment: Head of Global Pharmacovigilance
This is a unique opportunity to build and lead a team of pharmacovigilance specialists with a global pharmaceutical company.
Our client is a globally trading firm with facilities across the world. They have a well-deserved reputation as the market leader in their product category, with significant sales in territories such as the USA, Europe and Asia.
In recent years they have experienced significant success with elements of the product portfolio in a number of ‘new territories’. They have built up a large and well respected workforce in countries such as the USA, Canada, China and elsewhere.
The successful candidate will be tasked with developing and implementing a global regulatory strategy to enable the company to maximise their revenue in their target markets. The Head of Global Pharmacovigilance will lead a team of in-house specialists and external consultants to ensure that our client company can continue to grow their business.
The successful candidate can expect a market leading salary and benefits package. As this is a new role, we, along with our client, are willing to tailor a package to best suit the needs of the role holder.
- Assume responsibility as the EU Qualified Person for Pharmacovigilance (QPPV) with overall responsibility for the safety of the company’s products.
- Ensures the establishment and functioning of the company’s pharmacovigilance system
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 (PSUR), 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 officers 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.
- Reviews commercial agreements provided by Legal/ Commercial (where new are needed) and ensures appropriate level of cover is detailed in Pharmacovigilance Agreements (PVA) using approved template and meet local reg. requirements.
- Accountable to ensure local and global literature searches are performed by 3rd party partners.
- Provides oversight of all PV Inspections/audits/CAPAs and local remediation plans in collaboration with PV Team.
- Provide input to PV Training & evaluation standards.
- Maintains awareness of local PV Regulatory requirements & implementation plans.
- In-direct functional oversight of Distributor personnel with responsibility for PV activities.
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written).
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Demonstrated experience of proactively driving a team in a variety of tasks, projects and team management.
- Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds.
- Degree in Science (MSc, 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.
- Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
How to Apply
This role is being managed exclusively by Acorn Regulatory.
If you would like to have an initial confidential discussion regarding the role then please contact Brian Cleary at Acorn Regulatory on 00353 52 61 76 706.
Alternately, if you would like to submit your up to date CV for consideration, then please email: email@example.com
All applications will be treated in the strictest of confidence.