Position Summary:
The SERM Scientific Director will provide 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. This individual will ensure 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. In addition to this you will also make recommendations for the further characterization, management, and communication of safety risks.

• In this critical role, you will 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.
• Accountable for the product team level GSK asset Benefit Risk profile and Benefit Risk management.
• 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.

Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.
• Demonstrated 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 prioritize tasks and consistently delivers 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.
• Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams.
• Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams.
• Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations.
• Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being 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 displays excellent leadership skills on safety issues whilst working in a matrix team.
• Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees.
• Leads cross-functional process improvement team within GSK.
• Leads inspection readiness and prepared as needed to support audits/inspections.

Why You?
Basic Qualifications:

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Experience working in large matrix organizations.

Preferred Qualifications:

• Advanced experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety or a related field.
• Experience working in Oncology, specifically solid tumors.
• Experience supporting a product spanning both clinical development and post-marketing phases.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.