Safety Evaluation & Risk Management (SERM) Team Leader

Job Purpose

Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets 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 healthcare professionals globally. Supports pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure patient safety worldwide. If appointed as a manager (i.e., Team/Group Leader), is responsible for leadership of a team of individual contributors. Line management leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision-making, change management, partnership, and relations management.

Key Responsibilities

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 in clinical development and/or the post-marketing setting.

• Leads pharmacovigilance and risk management planning, developing strategies for evaluating issues in the clinical matrix.
• Oversees the safety component of global regulatory submissions.
• Demonstrates expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis, and interpretation.
• Ensures quality decision-making and creative problem resolution based on assessment of all relevant supporting and conflicting information/factors.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.
• Leads safety governance by developing and executing safety strategies for products in clinical development and post-marketing settings.
• Anticipates, detects, and addresses product safety issues (e.g., product incidents) and ensures risk-reduction strategies are implemented appropriately.
• Facilitates safety governance/SRTs by establishing and operating cross-functional teams to address product safety issues and ensure risk-reduction strategies are implemented in clinical study protocols and/or product labeling.
• Represents Global Safety on cross-functional Clinical Matrix Teams and/or Project Teams.
• Leads cross-functional ad hoc teams to address urgent and important product safety issues.
• Authors/participates in updates to written standards (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).
• Leads presentations on recommendations or safety issues to senior staff members at GSK Senior Governance Committees.
• Represents GSK and contributes to safety-related discussions at meetings with regulatory authorities, external consultants, and licensing partners.
• Leads cross-functional process improvement teams within GSK.
• Contributes to the development of long-term strategies for clinical programs.
• Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
• Leads inspection readiness and supports audits/inspections as needed.

We are looking for professionals with these required skills to achieve our goals:

• Requirements

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Advanced experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety, or a related field.
• Experience leading and managing team

If you have the following characteristics, it would be a plus:

• Preferred Qualifications

• Medical Doctor (physician) preferred (or equivalent, e.g., veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
• Experience with Vaccines
• 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.
• Strong communication (verbal and written) and influencing skills internally and externally.
• Ability to coach and mentor others.

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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