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Provides 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 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.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

• Be responsible for signal detection and evaluation activities for assigned products.
• Drive the production of regulatory periodic reports and associated documentation and Risk Management Plans (RMPs) globally, in line with agreed processes and timelines, advising on content in partnership with the Product Physician.
• Author the SERM safety contribution to global regulatory submissions in partnership with the Product Physician.
• Respond to auditor and inspector requests for information or additional information and complete corrective and preventative actions (CAPAs) within agreed timelines.
• Apply advanced evaluation skills and analytical thinking to literature review, data gathering, data synthesis, analysis, and interpretation.
• Make sound decisions based on relevant information gathered from a broad range of sources, seeking input as needed, and identifying, evaluating, and recommending solutions to problems.
• Demonstrate strong commitment to delivery by prioritising activities effectively, meeting multiple deadlines, and maintaining high performance standards and attention to detail.
• Support and facilitate safety governance and Safety Review Teams (SRTs) in clinical development and post-marketing settings by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues.
• Ensure that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Lead or participate in cross-functional process initiatives and Process Workstreams to improve adherence to regulations, data standards, quality, and efficiency.
• Author or contribute to written standard updates (e.g. SOPs) to ensure policies and regulations are applied consistently and correctly.
• Build strong collaborative relationships and demonstrate effective matrix leadership, proactively providing input to teams on safety issues and processes, including coaching and mentoring others as appropriate.
• Present complex issues to senior staff members and GSK Senior Governance Committees.
• Demonstrate initiative and creativity in performing tasks and responsibilities, proactively contributing ideas to improve existing operations.
• Participate in process improvement initiatives within GCSP and contribute to the advancement of methodologies and processes through new ideas and proposals for implementation.
• Communicate effectively within matrix teams, presenting ideas and data clearly and concisely, while listening and responding appropriately to feedback.
• Produce high-quality medical and scientific written outputs, including detailed evaluations and reports on major GSK products.
• Apply effective negotiation, influencing, and persuasion skills to enable understanding and alignment across matrix teams.

Why you?

Basic Qualifications & Skills:

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

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Substantial 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

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Advanced degree preferred.

Closing Date for Applications - 12th of May (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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.

Find out more:

Our approach to R&D.

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...