SERM Medical Director

Overview

Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or 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. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Scientific/Medical Knowledge PV Expertise

Responsibilities

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
• Demonstrates a track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
• Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently deliver on deadlines, with high performance standards for quality.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.
• Leads safety governance by development of safety strategy and its execution for products in clinical development and post-marketing settings. Anticipates, detects and addresses product safety issues and ensures that risk-reduction strategies are implemented appropriately.
• Facilitates safety governance/SRTs in the clinical development and post-marketing settings by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues and ensure risk-reduction strategies are implemented in study protocols and/or product labelling.
• Represents GSK on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.
• Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive adherence to regulations, data standards, quality and efficiency.
• Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are adhered to correctly and consistently.
• Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
• Builds strong working relationships and demonstrates leadership in a matrix setting; coaches and mentors others as needed.
• Communications (verbal, written) and Influencing (internal PV Governance and External LTs): Leads presentations on recommendations or safety issues to senior staff and represents GSK in safety discussions with regulators, external partners, and licensing partners.
• Leads cross-functional process improvement teams within GSK.
• Thinks tactically/strategically, considers internal and external environments when addressing safety issues and process changes; contributes to long-term strategy for clinical programs.
• Contributes innovative ideas to address new issues or improve existing operations.
• Leads inspection readiness and is prepared to support audits/inspections.
• Maintains excellent communication and influencing skills internally and externally.

Why You?

• Medical degree
• Advanced experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance or Drug Safety
• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, spanning clinical development and post-marketing activities
• Experience with Signal Detection and safety surveillance
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS) and drug development and approval processes
• Experience working in large matrix organizations

Preferred Qualifications

• Experience leading cross-functional safety governance or Senior Review Teams
• Experience with safety databases, safety systems configuration or validated computerized systems
• Project or change management experience within regulated environments
• Experience engaging with regulatory authorities or external safety working groups
• Track record mentoring or managing scientific colleagues in safety roles

What you will gain

You will expand your influence across global safety operations and develop skills in safety strategy, regulatory interactions and cross-functional leadership. The role gives you the chance to shape processes that protect patients and to grow your career within a global organisation committed to scientific rigour and collaboration.

Company context

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on vaccines and medicines, combining our understanding of the immune system with technology to transform lives. We are an Equal Opportunity Employer and committed to an agile working culture. See our FAQ and adjustments information for applicants.

Other notices

GSK does not accept referrals from employment businesses/agencies unless authorized. For information on adjustments or recruitment processes, contact .