Safety Evaluation and Risk Management, Principal Scientist

Wavre , Wallonia, Belgium

Type: n/a

Category: Healthcare & Pharma

Requirements: English
Company: WhatJobs
Region: Wavre , Wallonia

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Safety Evaluation and Risk Management, Principal Scientist, Wavre

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Client:

1849 GlaxoSmithKline Biologicals S.A.

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

f2f0f0c99fab

Job Views:

2

Posted:

03.05.2025

Expiry Date:

17.06.2025

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Job Description:

About the role

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, escalating safety concerns to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks.

Focuses on efficiency and effectiveness to meet the needs of Patients and HCPs. Supports pharmacovigilance and benefit-risk management of GSK''s global assets to ensure Patient Safety worldwide.

If appointed as a manager, is responsible for leading a team of contributors. Leadership competencies include resource management, coaching, influencing, collaboration, decision-making, change management, and partnership.

About the responsibilities

1. Scientific/Medical Knowledge PV Expertise

• Responsible for signal detection and evaluation activities for assigned products.
• Ensures accurate evaluation documents with clear conclusions for safety data requests.
• Assists in producing Risk Management Plans (RMPs)/Risk Tables for products, in consultation with senior staff.
• Authors regulatory reports and contributes to safety program documents.
• Participates in process improvement initiatives within GCSP.
• Completes audit/inspection activities timely.
• Uses diverse sources to gather information, proposes solutions, and makes decisions with consultation.
• Manages workload effectively, prioritizing multiple deadlines with attention to detail.

2. Cross-functional Matrix team leadership

• Builds effective relationships and responds to safety-related needs within the matrix organization.
• Supports safety governance by establishing and operating cross-functional teams to detect and address safety issues.
• Mentors junior colleagues, contributing to their evaluation and work skills, with early capability for Safety Lead role.

3. Communications and Influencing

• Shares ideas for process improvements.
• Adjusts behaviors based on environment changes.
• Handles ambiguity, remains resilient, focused, and optimistic under pressure.
• Communicates effectively, both verbally and in writing, including medical/scientific report writing.
• Supports safety risk positions and keeps manager informed.
• Presents and defends own viewpoints convincingly.

About you

Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pham D). Advanced degree preferred.

• Relevant pharmacovigilance or drug development experience.
• Experience in Safety Evaluation and Risk Management in clinical and post-marketing settings.
• Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP, CIOMS).
• Experience in large matrix organizations.

#LI-GSK

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Why GSK?

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

GSK is a global biopharma company committed to improving health through vaccines, medicines, and innovative science, focusing on infectious diseases, HIV, respiratory/immunology, and oncology.

Our success depends on our people. We aim to create an inclusive environment where everyone can thrive, grow, and feel valued.

Join us at this exciting moment to make a difference.

Important notice to Employment agencies

GSK does not accept unsolicited referrals. Agencies must obtain prior written approval before referring candidates. Unauthorized actions are considered without GSK''s consent.

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