GSK is looking for a Consumer Healthcare Safety (CHS) Manager to manage a new team in Poland, Warsaw.
Consumer Healthcare has a large portfolio of products including medicines, cosmetics, medical devices and dietary supplements.
In line with a risk-proportionate framework for product vigilance, the Consumer Healthcare Safety (CHS) Manager is accountable for the continued safety monitoring and safety evaluation of assigned products in clinical development and / or post-marketing setting.
You will coordinate and oversee activities performed by the team of CHS scientists.
Key responsibilities :
Provide scientific expertise. Ensure that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements.
Drive signal detection activities for products under responsibility of reporting scientists to identify, assess and escalate signals appropriately.
Provide strategic guidance and product safety expertise on cross-functional teams.
Support central labelling team in maintenance of product information for assigned products.
Drive signal detection for products under responsibility of reporting scientists using available methodologies (e.g. signal management tool, literature review, individual case awareness tool).
Guide utilisation of appropriate sources of information and database searches to retrieve relevant data for exploration / evaluation of safety signals.
Communicate, escalate and document outcomes of signal detection process.
Produce accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Provide strategic guidance on safety contribution to regulatory submissions for new products, formulations or indications, or in support to license renewals
Provide strategic guidance on safety input into development programs involving all product types, including clinical studies, real-word evidence, post-authorisation safety studies, pharmaco-epidemiological studies, sensory studies and associated documentation.
Lead implementation of risk minimisation strategies in relevant documents such as umbrella branding assessments and product labelling
Lead development of regulatory supporting documentation for labelling updates and present labelling recommendations at relevant forums.
Provide strategic guidance on safety component of Safety Data Exchange Agreements.
Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
Represent Consumer Safety Science on cross-functional project teams and contribute to process improvement initiative within Consumer Safety and broader organisation.
Mentor and train safety scientists on scientific aspects of signal evaluation methodology and support personal development.
Basic Qualifications :
Life Science University degree
Prior experience of people management
Sound knowledge in causality assessment and methodologies applicable to safety evaluation & risk management activities
Sound knowledge of the assigned therapeutic area and related disciplines (e.g. statistics)
In depth knowledge of relevant regulations for all product types
Good understanding of product lifecycle and applicable regulations in major markets
Sound knowledge of medical and drug terminology
Strong medical writing skills
Sound computing skills
GSK is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.
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