SERM Principal Scientist

GSK; Camden Town; Hybride; GBP 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

GSK is seeking a SERM Principal Scientist to provide medical and scientific leadership in safety evaluation and risk management across clinical development and post-marketing settings. You will ensure rigorous interpretation of safety data and drive decisions on risk communication for patients and healthcare professionals.

The role emphasizes cross-functional collaboration within a matrix structure, leading signal detection, RMP development, and regulatory reporting while delivering timely,

Qualifications

• Pharmacovigilance, safety evaluation and risk management experience.
• Experience in clinical development and post-marketing activities.
• Familiarity with international pharmacovigilance requirements.

Responsabilités

• Lead PV reviews and signal evaluation for assigned products.
• Prepare risk management plans and regulatory safety documents.
• Collaborate with cross-functional teams to address safety issues.
• Ensure timely safety reporting and inspection readiness.
• Provide scientific expertise to governance forums.

Connaissances

Digital Fluency

Enterprise Leadership

Influencing Without Authority

Pharmacovigilance

Presentation Techniques

Formation

Healthcare degree (BSc/MSc/PhD)

Description du poste

Job Title: SERM Principal Scientist

JobPurpose

Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products 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 (Healthcare Professionals). Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Key Responsibilities

Scientific/Medical Knowledge PV Expertise

• 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 - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
• Supports inspection readiness and completes any post audit/inspection activities within the required timeline.
• Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of Safety Lead/Group Lead.
• Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritise own workload with minimal guidance.

Cross Functional Matrix team leadership

Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.

Supports 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 (Safety Evaluation and Risk Management) to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.

Can explain knowledge and skills, and work in new situations.

Basic Qualifications

• Degree in Health Sciences, Pharmacy, Nursing or a related healthcare discipline, such as Bachelor of Science (BSc), Master of Science (MSc), Doctor of Philosophy (PhD), Registered Nurse (RN), Bachelor of Science in Nursing (BSN), Master of Science in Nursing (MSN), Nurse Practitioner (NP), Registered Pharmacist (RPh), Bachelor of Pharmacy (BPharm), or Doctor of Pharmacy (PharmD).
• Experience in pharmacovigilance, safety evaluation and risk management, covering clinical development and post-marketing activities.

Preferred Qualification

• Familiarity with international pharmacovigilance requirements and guidance, including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Pharmacovigilance Practices (GVP), and Council for International Organizations of Medical Sciences (CIOMS) guidance.
• Experience with drug development and regulatory approval processes.
• Experience working in a large, matrix organisatio n .

Work Arrangements

• Primary Location: GSK HQ
• Additional locations may be considered: NA
• This role follows GSK's hybrid working model, combining on-site collaboration with remote working flexibility.

Skills

• Digital Fluency
• Enterprise Leadership
• Influencing Without Authority
• Pharmacovigilance
• Presentation Techniques

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic a