414118 PV & Regulatory Oversight Lead, UK & Ireland (Associate Director)
The PV & Regulatory Oversight Lead for the UK & Ireland is an integral role within GlaxoSmithKline (GSK), responsible for guiding and overseeing the pharmacovigilance (PV) and regulatory compliance functions in these key markets. This role is integral to ensuring patient safety and adherence to regulatory standards, while driving strategic initiatives to optimize PV and regulatory processes.
In this role you will
* Pharmacovigilance:
o Maintain local regulatory requirements for PV and MI, as appropriate
o Oversee adherence to in-scope product EU & GB/UK Risk Management Plans and associated Risk Minimisation Activities
o Define a compliant process for the tracking of Healthcare Professional communications (DHCPL and DIL)
o Supports the preparation, execution and close out of health authority inspections and internal audits
o Lead the cross-functional coordination required for Defective Medicines Report Centre (DMRC) responses
o Leads cross-functional input required for robust QPPV oversight of the UK Pharmacovigilance System
o Input as required into Medical Governance oversight processes
o Performs root cause analysis and defines robust CAPA plans for PV risk mitigation
o Inputs into the Local Risk Register as required
* Regulatory:
o Establish a stakeholder network for the management of GB/UK Risk Management plans and associated activities, including continuous oversight of the UK product strategies
o Act as back-up Named Safety Contact (NSC) for regulatory oversight activities
o Lead the cross-functional coordination of GB/UK Risk Management plans including GB/UK Annexes and associated activities, accountable for overall quality
o Liaise with aligned departments in GSK for complex query resolution in relation to the Pharmacovigilance System
o Continually evaluate the strategic approach to regulatory activities and drive improvements to meet the changing needs of the organisation, regulatory requirements and industry best practices
o Define, oversee and perform management monitoring for associated regulatory activities
o Ensure rapid communication of critical quality risks and issues and drives issue resolution
o Lead monthly oversight meetings with the Local Regulatory teams, alongside Named Safety Contact
* Other:
o Leads multidisciplinary or cross-functional work/project teams
o Provides guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Degree in pharmacy, pharmacology, relevant life science qualification or medically related degree, with a good understanding of medical and drug terminology
* Working knowledge of, and experience of working with, Pharmacovigilance regulations, with significant working knowledge in Pharmacovigilance methodology
* Knowledge of GVP, GCP, pharmacovigilance/drug safety and regulatory requirements
* Experience in drug development, pharmacovigilance operations, regulatory compliance or quality management
* Experience managing key stakeholders
* Ability to assimilate and interpret information relating to the field of drug safety
* Ability to present information clearly and logically, both orally and in written form
* Ability to prioritise and organise workload, for oneself and others and think clearly under pressure and time constraints
* Good understanding of commercial business objectives and external healthcare & Pharmacovigilance environment
* Experience of involvement in external regulatory inspections and audits
* Computer literate
Closing Date for Applications – March 16th, 2025 (COB)
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
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