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The SERM, Associate Medical Director will provide medical and scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. 

He/She will 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. The SERM, Associate Medical Director will make recommendations for the further characterization, management, and communication of safety risks. 

The SERM, Associate Medical Director will also 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. 

In this role you will…

• 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 
• 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. 
• Presents complex issues to senior staff members at the GSK Senior Governance Committees. 

Why you? 

Qualifications & Skills: 

• Medical Doctor (physician), with additional relevant medical or scientific post-graduate qualifications. 
• 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. 

Closing Date for Applications – September 15th, 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert. 

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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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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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

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