Safety, Evaluation
4 weeks ago
Site Name: Belgium-Wavre, UK – London – New Oxford Street
Posted Date: Dec 13 2024
Job Purpose:Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure scientifically sound review and interpretation of data and management of safety issues and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate. Make 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.
Your Responsibilities: Scientific/Medical Knowledge PV Expertise- Responsible for signal detection and evaluation activities for assigned products.
- Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory periodic reports (in partnership with the product physician).
- Author the SERM safety contribution to global regulatory submissions in partnership with the product physician.
- May respond to auditors/inspectors’ requests for information and completes corrective and preventative actions (CAPAs) within agreed timelines.
- Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
- Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identify, evaluate, and recommend solutions to problems.
- Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.
- Support and facilitate safety governance/SRTs in the clinical development and post-marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensure that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
- Lead or participate in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality, and efficiency.
- May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
- Build strong collaborative relationships and demonstrate good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.
- Present complex issues to senior staff members at the GSK Senior Governance Committees.
- Demonstrate initiative and creativity in performing tasks and responsibilities. Proactively contribute ideas to improve existing operations.
- Participate in process improvement initiatives within GCSP and contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
- Possess effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listen and respond appropriately to the views and feedback of others.
- Robust medical/scientific writing skills are essential, as the preparation of detailed evaluations and reports on major GSK products is a core feature of the role.
- Effective negotiation, influencing and persuasion to enable others in the matrix to understand own perspective.
We are looking for professionals with these required skills to achieve our goals:
- Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
- Substantial experience in pharmacovigilance or drug development.
- Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- 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.
Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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