Safety Manager, SERM (Safety Evaluation and Risk Management), Consumer Health
Biomedical /Science based Degree (Bachelors)
A robust knowledge of regulatory processes (European and Global) required to ensure GSK meets standards for patient safety for all of its Consumer Health products.
An ability to assess risk benefit of products to ensure patient safety is maintained at all times.
An ability to propose updates to product labels when required, in order to ensure health care professionals and consumers are aware of all product risks and to enable safe use of products in consumers/patients
Skilled communicator and conflict manager; demonstrates skills in networking, collaborating and engaging people internally and externally and can communicate in situations requiring tact and diplomacy. Has good cross functional awareness and an ability to negotiate and influence at various levels.
Presents ideas effectively to individuals or groups. Uses appropriate interpersonal styles and communication methods to gain acceptance of an idea.
Must be able to manage and lead in a matrix environment and is an enterprise thinker.
Proactively generates ideas for improvements and takes actions to solve problems and achieve goals by identifying the underlying issues and recognizing trends.
Appetite for change; is adaptable to the changing environment and shows a willingness to adjust behaviours and priorities based on business need.
Ability to think in terms of the big picture while also maintaining an appropriate attention to detail. Shares complete and accurate information while maintaining confidentiality.
Uses excellent analytical skills, and makes decisions with sound judgment.
In the Global Clinical Safety Department,you will be responsible for processes in safety evaluation and risk management for a wide range of products in the Consumer Health portfolio, which may include over the counter medicines, cosmetics , medical devices and nutritional.
You will provide medical support to the proactive monitoring and evaluation of all aspects of the safety profile of a large number of designated products and ensure that optimal decisions are made.
Specific key responsibilities will include;
In conjunction with the safety physician, proactively monitor and evaluate all aspects of the safety profile of designated products and ensure that optimal decisions are made at all stages of the product lifecycle.
Conducts, or leads with guidance, the discussion and management of safety issues through matrix teams across the global organisation and the presentation of findings to GSK governance bodies.
Provide safety support to innovation within GSK Consumer Healthcare and to switches from prescription to over-the counter status.
Act as an ambassador for GSK in representing safety within the external environment including interactions with regulatory authorities, licensing partners and external expert groups.
Ensure that safety documents (e.g. periodic reports, signal evaluations, labeling documents, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirement.
You may apply for this position online by selecting the Apply now button.
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