Job Description

Business Introduction
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 discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
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Job Purpose
Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products 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.
If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
Key Responsibilities
Scientific/Medical Knowledge PV Expertise

• Responsible for signal detection and evaluation activities for assigned products.
• Ensures that accurate and fit-for-purpose evaluation documents with clear conclusions are provided in response to internal or regulatory authority requests for safety data.
• Assists in the production of Risk Management Plans (RMPs)/Risk Tables for designated products, in consultation with senior personnel.
• Authors regulatory periodic reports and associated documentation globally according to the agreed process and timelines - reviews and contributes to production of program documents such as protocols and aggregate safety reports.
• Acts as a member of a process improvement initiative team within GCSP.
• Completes any post audit/inspection activities within the required timeline
• Uses a range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues/problems, and makes decisions with consultation of SERM physician.
• Shows commitment to the task and effective time management to meet multiple deadlines successfully and with attention to detail and quality. Able to prioritise own workload with minimal guidance.

Cross-functional Matrix team leadership

• Builds effective working relationships and responds to the needs of line functions in the matrix in relation to safety issues.
• Supports safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Mentoring of junior SERM colleagues, can contribute to evaluating the activities of junior colleagues. Can explain knowledge and skills, and work in new situations. Early capability for Safety Lead role.

• Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
• Shares ideas with line manager on ways to improve processes for assigned tasks.
• Ability and willingness to adjust behaviours and priorities based on changing environment.
• Able to deal with ambiguity and resilient, focused, and optimistic under pressure.
• Demonstrated effectiveness in both oral and written communication. Able to effectively express ideas and incorporate feedback into deliverables to create a quality output.
• Thorough medical/scientific writing skills are important, as the preparation of detailed evaluations and reports is a core feature of the role.
• Supports a safety risk position
• Keeps manager/supervisor informed of progress and activities; escalates issues as appropriate.
• Able to present merits of own point of view.

Education Requirements (minimum expected)
Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
Relevant experience in pharmacovigilance or drug development.

• 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

Scope of Accountability
Safety signal detection, assessment, and risk management. May chair Safety Review Team.
Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.
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.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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Skills Required