SERM Director, Safety Scientist

ENGINEERINGUK; London; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player seeks a Director to lead medical and scientific staff in clinical safety and pharmacovigilance. This pivotal role involves defining and driving strategies aligned with global safety initiatives, ensuring effective risk management, and fostering collaboration across departments. The ideal candidate will possess a strong background in Drug Safety, excellent communication skills, and a proven ability to influence and lead in a matrix environment. Join this innovative firm in its mission to enhance patient safety and health outcomes worldwide.

Qualifications

• Extensive experience in Drug Safety or Pharmacovigilance.
• Expertise in clinical safety and risk management.

Responsibilities

• Lead medical and scientific staff in clinical safety activities.
• Implement safety strategies and manage safety issues.

Skills

Clinical Safety

Pharmacovigilance

Regulatory Safety Reports

Analytical Skills

Risk Management

Communication Skills

Education

Health Sciences/Health Care Professional degree

Advanced Degree

Job description

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View more categories | View less categories | Sector: Health and Safety, Science and Pharmaceutical | Role: Director | Contract Type: Permanent | Hours: Full Time

Site Name: UK - London - New Oxford Street, Mississauga, Poznan Grunwaldzka, Warsaw Rzymowskiego 53
Posted Date: May 8, 2025

Job Purpose

Responsible for leading medical and scientific staff within the SERM (Safety Evaluation & Risk Management), defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.

As a senior member of the Global Safety organization, the role is responsible to:

• Implement policy, processes, and support the implementation of operational and strategic plans
• Ensure scientifically sound review and interpretation of data, management of safety issues, and escalate safety issues identified through the safety review process to senior management and safety governance as appropriate. Make recommendations for further characterization, management, and communication of safety risks
• Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs, supporting 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

• Expert in clinical safety and pharmacovigilance activities.
• Demonstrated record of sound judgment and decision-making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and proactive risk management strategies.
• Coaches and mentors SERM colleagues in scientific/medical aspects of signal evaluation methodology and risk management, including regulatory safety reports.
• Proven quality decision-making and problem resolution skills in critical situations.
• Provides excellent medical/scientific judgment, strong analytical skills, and a proactive approach in drug safety with a high sense of urgency.
• Champions safety governance by developing safety strategies and executing them for products in clinical development and post-marketing settings.
• Leads cross-GSK activities such as safety advisory panels and interfaces with Senior Governance Committees.
• Engages confidently and professionally in the broader GSK and pharmacovigilance environment outside GSK.

Cross-functional Matrix Team Leadership

• Leads safety governance development and addresses safety issues, ensuring proper risk-reduction strategies.
• Incorporates global considerations into decision-making processes.
• Builds strong collaborative relationships and demonstrates leadership in a matrix team environment.
• Adapts behaviors and priorities as needed based on environmental changes.
• Oversees SERM contributions to due diligence activities.

Communications & Influencing

• Excellent verbal and written communication skills.
• Leads safety activities and influences internal and external stakeholders to meet organizational objectives.
• Drives change management initiatives.
• Recognized as an authority in pharmacovigilance regulations and methodologies.

Why you?

Basic Qualifications

• Health Sciences/Health Care Professional degree (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists, Veterinarians)
• Experience in Drug Safety or Pharmacovigilance within the Pharmaceutical or Biotech industry
• Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP, CIOMS) and drug development processes

Preferred Qualifications

• Advanced Degree
• Experience in large matrix organizations
• Experience in Oncology

Why GSK?

GSK is a global biopharma company dedicated to uniting science, technology, and talent to combat disease, impacting billions of lives with innovative medicines and vaccines, especially in infectious diseases, HIV, respiratory/immunology, and oncology.

We prioritize a workplace where people can thrive, feel valued, and grow, emphasizing diversity, inclusion, and wellbeing. Join us to be part of our journey to get Ahead Together.