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- Tasks: Lead safety evaluations and risk management for GSK's clinical assets.
- Company: GSK is a global biopharma company focused on advancing health through science and technology.
- Benefits: Enjoy a collaborative culture, opportunities for growth, and a focus on wellbeing.
- Why this job: Make a real impact on patient safety while working in a dynamic, innovative environment.
- Qualifications: Medical Doctor or equivalent with experience in pharmacovigilance and drug development.
- Other info: Join us to thrive in a diverse and inclusive workplace.
The predicted salary is between 48000 - 84000 £ per year.
Nombre del sÃtio: Belgium-Wavre, UK – London – New Oxford Street
Fecha de publicación: Jul 9 2025
About the role
Provides medical/scientific expertise in the safety evaluation and risk management of key GSK assets 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.
If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
About the responsibilities
1.Scientific/Medical Knowledge PV Expertise
- Responsible for signal detection and evaluation activities for assigned products.
- Drives production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).
- Authors the SERM safety contribution to global regulatory submissions in partnership with the product physician.
- May respond to auditors/inspectors’ requests for information/additional 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.
- Makes sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed. Identifies, evaluates, and recommends solutions to problems.
- Committed to the task and able to prioritize activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.
2.Cross-functional Matrix team leadership
- Supports and Facilitates 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 ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
- 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.
- May author/participate in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
- Builds strong collaborative relationships and demonstrates good matrix leadership skills, proactively providing input to matrix teams on safety issues and processes. Ability to coach and mentor others.
3.Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
- Presents complex issues to senior staff members at the GSK Senior Governance Committees.
- Demonstrates initiative and creativity in performing tasks and responsibilities. Proactively contributes ideas to improve existing operations.
- Proactively contributes ideas to improve existing operations.
- Participates in process improvement initiatives within GCSP and contributes to advancement of methodology and process by generating new ideas and proposals for implementation.
- Possesses effective communication skills and is capable of presenting ideas and data clearly and concisely to a matrix team. Listens and responds 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.
About you
- 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
- Fluency in English
#LI-GSK
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Si tiene una discapacidad y necesita asistencia durante el curso del proceso de selección, tendrá la oportunidad de hacernos saber qué asistencia especÃfica necesita para hacer los arreglos adecuados.
Nuestro objetivoes ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increÃble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.
Aviso importante a las empresas o agencias de empleo
GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.
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SERM Medical Associate Director employer: GlaxoSmithKline
Contact Detail:
GlaxoSmithKline Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SERM Medical Associate Director
✨Tip Number 1
Familiarise yourself with the latest pharmacovigilance regulations and guidelines, especially those related to safety evaluation and risk management. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the pharmacovigilance and drug development sectors. Attend relevant conferences or webinars where you can meet industry experts and learn about current trends. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific case studies or examples from your past experience that highlight your skills in signal detection, data analysis, and cross-functional team leadership. Being able to articulate your contributions to previous projects will set you apart during the interview process.
✨Tip Number 4
Showcase your communication skills by practising how to present complex medical information clearly and concisely. You might even consider conducting mock interviews with a friend or mentor to refine your ability to convey your ideas effectively, as this is crucial for the role.
We think you need these skills to ace SERM Medical Associate Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in pharmacovigilance and drug development. Emphasise your medical qualifications and any specific projects that demonstrate your expertise in safety evaluation and risk management.
Craft a Strong Cover Letter: In your cover letter, clearly articulate why you are interested in the SERM Medical Associate Director position at GSK. Mention your understanding of their mission and how your skills align with their needs, particularly in relation to patient safety and cross-functional leadership.
Highlight Communication Skills: Given the importance of communication in this role, provide examples of how you've effectively communicated complex medical information in previous positions. This could include presentations to senior staff or contributions to regulatory submissions.
Showcase Leadership Experience: If you have experience leading teams or projects, make sure to highlight this in your application. Discuss your approach to coaching and mentoring others, as well as any successful initiatives you've led that improved processes or outcomes.
How to prepare for a job interview at GlaxoSmithKline
✨Showcase Your Medical Expertise
As a SERM Medical Associate Director, it's crucial to demonstrate your deep understanding of pharmacovigilance and risk management. Be prepared to discuss your previous experiences in safety evaluation and how you've contributed to patient safety in clinical development or post-marketing settings.
✨Highlight Cross-Functional Leadership Skills
This role requires strong matrix leadership abilities. Share examples of how you've successfully led cross-functional teams, facilitated safety governance, and implemented risk-reduction strategies. Emphasise your ability to coach and mentor others in these settings.
✨Prepare for Complex Communication Scenarios
Effective communication is key in this position. Be ready to present complex safety issues clearly and concisely to senior staff. Practice articulating your thoughts on safety evaluations and regulatory submissions, ensuring you can convey your ideas confidently.
✨Demonstrate Problem-Solving Skills
The ability to identify, evaluate, and recommend solutions to problems is essential. Prepare to discuss specific challenges you've faced in your career and how you approached them. Highlight your analytical thinking and decision-making processes, especially in high-pressure situations.
