Safety Risk Scientist
In conjunction with the safety physician, the SERM (Safety Evaluation & Risk Manager) performs signal detection activities to identify, assess and escalate signals appropriately. In this role you will conducts, or lead with guidance, the discussion and management of safety issues through matrix teams across the global organization and the presentation of findings to companies governance bodies.
In addition, this role will author regulatory documents (e.g. PBRERs, renewal documents, risk management plans, submission documents) according to the agreed process and timelines. You will contributes to labelling updates by preparing documentation and presenting to relevant boards. The SERM will participate in project-focused meetings and provide safety expertise along with safety physician. You will contributes to the advancement of methodology and process within safety by generating new ideas and proposals for implementation. As part of a multifunctional project team, this role will contribute to the safety assessment of Innovation and Switch products in the Consumer Health portfolio with intention to bringing new company products onto market.
These responsibilities include some of the following:
Safety Governance and Risk Management activities
• Contributes to regulatory benefit-risk assessments, authors Risk Management Plans for designated
products for submission to regulatory authorities
• Provides support and input into Clinical Development planning activities, as required
• With guidance, represents SERM on cross-functional project teams
• Reviews and may provide technical approval for investigator brochures, protocols, informed consents,
final study reports and external data monitoring committee charters. Ensures prompt notification to SERM
Head of any reviewed protocols that are identified as potential PASS
• Ensures that risk-reduction strategies are implemented appropriately in in relevant documents such as
umbrella branding assessments and/or product labelling
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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