Hybrid SERM Principal Scientist - Safety & Risk

GSK; Irvine; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

GSK is seeking a SERM Principal Scientist to provide medical and scientific expertise in safety evaluation and risk management for products in clinical development and post-marketing settings. You will drive pharmaceutical safety across the portfolio, ensuring robust assessment and communication of safety risks.

The role emphasizes signal detection, risk management planning, regulatory reporting, and cross-functional collaboration to support global patient safety and governance.

Qualifications

• Degree in Health Sciences, Pharmacy, Nursing or a related healthcare discipline, such as BSc, MSc, PhD.
• Registered Nurse (RN), BSN, MSN, NP, RPh, BPharm or PharmD qualification.
• Experience in pharmacovigilance, safety evaluation and risk management across clinical development and post-marketing.

Responsibilities

• Responsible for signal detection and evaluation activities for assigned products.
• Input into review and assessment of clinical and post-marketing safety data to identify and manage potential risks.
• Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
• Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
• Contributes to authoring of regulatory periodic reports and associated documentation globally according to the agreed process and timelines.
• Supports inspection readiness and completes post audit/inspection activities within required timelines.

Skills

Digital Fluency

Enterprise Leadership

Influencing Without Authority

Pharmacovigilance

Presentation Techniques

Education

BSc in Health Sciences/Pharmacy/Nursing

MSc/PhD or related clinical qualification

RN/NP/RPh/BSN/MSN/PharmD qualification

Job description

GSK is seeking a SERM Principal Scientist to provide medical and scientific expertise in safety evaluation and risk management for products in clinical development and post-marketing settings. You will drive pharmaceutical safety across the portfolio, ensuring robust assessment and communication of safety risks.

The role emphasizes signal detection, risk management planning, regulatory reporting, and cross-functional collaboration to support global patient safety and governance.