Associate Medical Director, Safety Evaluation and Risk Management (SERM)

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.
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Position Summary

As Associate Medical Director, Safety Evaluation and Risk Management (SERM), you will provide medical/scientific expertise in the safety evaluation and risk management of GSK assets in clinical development and/or the post-marketing setting. You will contribute to clinical safety and pharmacovigilance strategy for assets within Global Safety.  Working in a global, cross-functional matrix, you will collaborate with senior governance and partner teams to drive evidence-based safety decisions.

You will provide medical leadership across clinical programs, contribute to clinical trial design, safety oversight, and scientific communication. You will work closely with cross-functional teams including Clinical Operations, Safety, Regulatory, Biostatistics, and Commercial. We value clear scientific judgment, collaborative leadership, and a focus on patients. This role offers growth and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.

You will ensure 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 and make recommendations for the further characterization, management, and communication of safety risks.

Key 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 prioritise 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 co