Director, Signal Detection Scientist

Product Safety

Pharmacovigilance

Scientific/Technology

High Wycombe, Buckinghamshire, United Kingdom

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States: R-101409 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for Director, Signal Detection Scientist.

Purpose:

The Director, Signal Detection Scientist will lead the implementation of the Signal Management Group surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from post-marketing safety data for complex pharmaceutical products (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships). These activities include the development, evaluation, piloting, as well as use of novel, computer-assisted tools and methodologies for signal detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, e.g., claims and electronic medical records.

The Director, Signal Detection Scientist will function at a high level of safety and scientific acumen, competence, and leadership to independently develop and implement product-specific surveillance plans, perform post-marketing signal detection activities, including signal validation, and participate in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings. This individual will function at a high level of independence and consistently deliver high-quality results with minimal guidance, quickly building alliances and independently influencing other safety partners to shape strong decisions/outcomes.

The Director, Signal Detection Scientist will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis and may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA AEMS, WHO Vigi Base, and EMA Eudra Vigilance databases. This role also may involve leadership and support of exploration of new signal detection methodologies, tools, and data sources to further the science of safety surveillance.

You will be responsible for:

• Lead signal detection activities and assess new safety signals and trends for assigned complex/innovative products using the Company safety platforms through systematic reviews of aggregate safety data, e.g., spontaneous and noninterventional adverse event reports.
• Lead signal validation activities including strategy discussions, collaborating with Global Safety Strategy & Risk Management (GSSRM) and other stakeholders as necessary.
• Prepare high-quality reviews of topics and summary analysis reports of safety data.
• Communicate findings to Medical Safety Officers and the Safety Management Teams (SMTs) and provide recommendations for further evaluation, as applicable.
• Provide guidance and work with key customers and business partners (physicians, scientists) in developing and implementing product-specific surveillance plans.
• Demonstrate leadership in the SMT and other cross-functional forums and provide support as needed.
• Support SMT activities (e.g., preparing and presenting data) and provide input and review key regulatory or clinical documents, as appropriate.
• Leverage expert product knowledge to participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis.
• May also perform activities supporting signal evaluation, such as ad hoc data mining of FDA AEMS, WHO Vigi Base, and EMA Eudra Vigilance and the Global Safety Database.
• Drive the development and implementation…