You will need to login before you can apply for a job.
View more categories | View less categories | Sector: Health and Medical | Role: Director | Contract Type: Permanent | Hours: Full Time
Site Name: GSK HQ, Belgium-Wavre, Mississauga, Warsaw Rzymowskiego 53
Posted Date: May 9, 2025
Job Purpose
Responsible for leading medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and 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 worldwide.
Key Responsibilities
Scientific/Medical Knowledge & PV Expertise
- Expert in clinical safety and pharmacovigilance activities.
- Proven 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, risk management, and regulatory safety report preparation.
- Demonstrated quality decision-making and problem resolution skills in critical situations.
- Provides excellent medical/scientific judgment, strong analytical skills, proactive drug safety approach, and a high sense of urgency.
- Champions safety governance by developing safety strategies and executing them for products in clinical development and post-marketing.
- Leads cross-GSK activities such as safety advisory panels and interfaces with senior governance committees.
- Ability to contribute confidently and professionally to broad pharmacovigilance environments inside and outside GSK.
Cross-functional Matrix Team Leadership
- Champions safety governance by developing and executing safety strategies, addressing product safety issues, and implementing risk-reduction strategies.
- Ability to influence department and product strategies considering global factors.
- Builds strong collaborative relationships and demonstrates leadership in a matrix environment.
- Shows resilience and adaptability to changing environments.
- Leads or oversees SERM contributions to due diligence activities.
Communications & Influencing
- Excellent verbal and written communication skills.
- Leads cross-GSK safety activities, influences external stakeholders, and may participate in external pharmacovigilance initiatives.
- Drives change management effectively.
- Recognized authority in pharmacovigilance regulations and methodologies applicable to SERM activities.
Why you?
Basic Qualifications
- Health Sciences/Health Care Professional degree (e.g., PharmD, PhD, BSN/MSN/NP, BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists, Veterinarians).
- Extensive experience in the pharmaceutical or biotech industry in drug safety or pharmacovigilance, covering clinical development and post-marketing activities.
- Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP, CIOMS) and drug development processes.
Preferred Qualifications
- Advanced Degree.
- Experience working in large matrix organizations.
- Experience in Oncology/Immunology.
Why GSK?
We unite science, technology, and talent to get ahead of disease, positively impacting global health and delivering sustainable shareholder value. We focus on vaccines, specialty, and general medicines, investing in immunology, infectious diseases, HIV, and respiratory areas.
Our success depends on our people. We aim to create a workplace where everyone feels valued, inspired, and encouraged to grow and thrive. Join us in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. We promote an inclusive culture and support flexible working arrangements. For adjustments in our hiring process, contact us at Ukdiversity.recruitment@gsk.com or 0808 234 4391.
Note: GSK does not accept referrals from employment agencies without prior authorization. For US Healthcare Professionals, we may need to report expenses related to interviews to comply with transparency laws. More info at https://openpaymentsdata.cms.gov/