Safety Scientist (ASSOCIATE DIRECTOR)

Site Name: Warsaw Posted Date: Nov 24 2022 A fantastic opportunity to join a high-performing team and be supported in your development within the clinical development space. The ideal candidate will be enthusiastic and eager to learn, and they will benefit from exposure to leading-edge clinical safety in GSK’s exciting development pipeline. Safety Scientist (Associate Director) In this role you will… Provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for labelling updates and drive proactive implementation of risk management initiatives. Has the ability to guide safety evaluation activities, ensuring that appropriate safety objectives and risk minimization strategies are included in clinical development programs. Show confidence, credibility and the ability to communicate effectively at all levels of the organization. SAFETY GOVERNANCE AND RISK MANAGEMENT ACTIVITIES: Drives pharmacovigilance and risk management planning in the clinical matrix Contributes to production of global Risk Management Plans for designated products. Reviews and provides input to investigator brochures, protocols, Informed consent forms, final study reports and external data monitoring committee charters. Contributes safety input into regulatory benefit-risk assessments. Delivers the clinical safety input into clinical development planning activities. Represents Global Safety on cross functional Clinical Matrix Teams and/or Project Teams. Participates in cross-functional ad hoc teams to address urgent and important product safety issues. Actively participates in the Safety Review Team (SRT) for projects in development and provides review of data and management of safety issues. Escalates safety signals identified through the Safety Review Process to Global Safety Board. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate. SIGNAL DETECTION, EVALUATION AND LABELLING: Drives signal detection for assigned products using available methodologies. Makes recommendations to SERM Team Leader for the assessment and prioritization of safety signals. Proactively leads the assessment of safety data and discusses the results with the SERM Safety Lead/physician. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations. Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion. REGULATORY REPORTS AND SUBMISSIONS: Drives production of periodic regulatory documents (e. g. DSURs) according to the agreed process and timelines. Advises on strategy for the content of safety reports. Contributes to the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts. OTHER SAFETY EVALUATION AND RISK MANAGEMENT (SERM) ACTIVITIES: Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities. Accountable for maintaining personal readiness in response to internal audit or regulatory inspection. Participates in process improvement initiatives within Global Safety. Raises concerns/ issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated EDUCATION, KNOWLEDGE AND TECHNICAL EXPERIENCE: Degree in Biomedical, Pharmacy or Health Care related specialty Experience in clinical safety, pharmacovigilance and/or clinical research settings. Strong knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities. Understanding of causality assessment, evaluation of safety signals and proactive risk management strategies. Clear understanding of clinical development process. Sound knowledge of other related disciplines, e. g. statistics, epidemiology relevant to assessing safety at the population level Strong evaluation skills and analytical thinking Strong medical writing and computing skills Fluent English BEHAVIOURAL COMPETENCIES: Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context. Proven leadership skills in a matrix team setting. Ability to manage and co-ordinate tasks, projects and processes across a large organization. Effective communication skills; able to present complex data to groups at all levels of the organization and externally to GSK. Demonstrated ability to prioritize multiple tasks and deliver to deadline with high standard of quality. Ability to adjust behaviors and priorities based on changing environment. Ability to engage in, and contribute to, broad GSK environment with confidence, impact, integrity and professionalism. Eagerness to learn and develop within the role. Why GSK? Career at one of the leading global healthcare companies, Contract of employment, Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit), Life insurance and pension plan, Private medical package with additional preventive healthcare services for employees and their eligible counterparts, Company Car or Car Allowance, Long term incentives, Sports cards (Multisport), Possibilities of development within the role and company’s structure, Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training), Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities), Supportive community and integration events, Modern office with creative rooms, fresh fruits every day, Free car and bike parking, locker rooms and showers. Inclusion & Diversity at GSK: Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team ([email protected]) to further discuss this today. We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application.
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