# SERM Principal Scientist

**Company**: GSK
**Location**: London, New Oxford Street
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/UK--London--New-Oxford-Street/SERM-Principal-Scientist_449321-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_1535bf57-cdc

## Description

We are seeking a SERM Principal Scientist to provide medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.

The successful candidate 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.

**Key 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 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.

**Basic Qualifications**

- Degree in Health Sciences, Pharmacy, Nursing or a related healthcare discipline.

- 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 ICH, GVP, and CIOMS guidance.

- Experience with drug development and regulatory approval processes.

- Experience working in a large, matrix organisation.

**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

### Required
- Pharmacovigilance
- Digital Fluency
- Enterprise Leadership
- Influencing Without Authority
- Presentation Techniques

### Nice to have
- ICH
- GVP
- CIOMS guidance
- drug development
- regulatory approval processes

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