Overview
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Position Summary
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Key Responsibilities
* Scientific/Medical Knowledge PV Expertise
* Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
* Leads the safety component of global regulatory submissions.
* Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
* Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
* Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
* Explores positions and alternatives to reach mutually beneficial agreements and solutions.
* Cross-functional Matrix team leadership
* Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues and ensures that risk-reduction strategies are implemented appropriately.
* Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
* Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
* Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
* Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
* Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
* Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting. Ability to coach and mentor others.
* Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
* Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Interacts with confidence, credibility, and influence at all levels of the organisation. Represents GSK and contributes to safety discussions with regulatory authorities, outside consultants and licensing partners.
* Leads cross-functional process improvement team within GSK. Contributes to development of long-term strategy for clinical programs and to innovative ideas for addressing new issues or improving operations.
* Leads inspection readiness and is prepared to support audits/inspections.
* Excellent communication and influencing skills (verbal and written, internal and external).
Why You?
Basic Qualification
* Medical degree
* Completion of a formal postgraduate clinical training, clinical residency or specialty training
* Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety
* Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities
* Experience with Signal Detection and safety surveillance
* Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes
* Experience working in large matrix organizations
Preferred Qualification
* Experience leading cross-functional safety governance or Senior Review Teams
* Immunology SERM background
* Experience with safety databases, safety systems configuration or validated computerized systems
* Project or change management experience within regulated environments
* Experience engaging with regulatory authorities or external safety working groups
* Track record mentoring or managing scientific colleagues in safety roles
* Advanced specialty training or country-equivalent higher-level qualification in Immunology with certification
What you will gain
You will expand your influence across global safety operations and develop skills in safety strategy, regulatory interactions and cross-functional leadership. The role gives you the chance to shape processes that protect patients and to grow your career within a global organisation committed to scientific rigour and collaboration.
Working model
This role is hybrid, based in the United Kingdom. You will be on site for key meetings, governance activities and team collaboration. Remote working is supported to balance focus time and effective stakeholder engagement.
How to apply
If this role speaks to you, please apply with your CV and a short note describing a safety assessment or risk management activity you led and its impact. We encourage candidates from many backgrounds to apply.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com. You can also request a call. If your inquiry does not relate to adjustments, we will not be able to support you through these channels. A Recruitment FAQ guide is available via the provided link.
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