We have an exciting opportunity for an exceptional Safety Scientist in Safety Evaluation and Risk Management supporting critical and exciting research for Covid-19.
As a Safety Scientist, you will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level.
This role will provide the opportunity to lead key activities. These responsibilities include some of the following:
Safety Governance and Risk Management activities
• Drives pharmacovigilance and risk management strategy in the clinical matrix team
• Leads safety input into benefit-risk assessments and risk management plans
• Delivers the clinical safety input into clinical development planning activities
• Represents SMG on cross functional Clinical Matrix Teams and/or Project Teams.
• Leads cross-functional teams to address urgent and important product safety issues
• Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and data monitoring committee charters.
• Leads or participates in discussion at Global Safety Board for safety related issues.
• Presents safety information at clinical investigator meetings, commercial meetings, matrix team meetings, regulatory authority meetings, and at governance boards.
• Establishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues.
• Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the Pharma Safety Head.
• Accountable for ensuring that risk minimization 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
• Makes recommendations to Pharma Safety Team Leader for the assessment and prioritisation of safety signals
• Proactively leads the assessment of safety data and discusses the results with the Pharma Safety Team Leader/ product physician and safety scientist
• Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
• Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
• Produces regulatory supporting documentation for labelling updates
• Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data.
• Provides strategic input into regulatory requests
• Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints
• In consultation with the product physician and Clinical Development representatives, 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 (PBRERs, DSURs) according to the agreed process and timelines.
• Supports the Local Operating Companies by preparing license renewal documentation as required for each market
• Leads the Pharma Safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
Other Pharma Safety Activities
• Drives the review or production of the Pharma Safety component of Safety Data Exchange Agreements and escalates any deficiencies to the Pharma Safety Head to ensure quality and integrity of agreement.
• Advises on the preparation of licensing agreements in therapeutic area of responsibility
• Participates in due diligence activities by providing expert safety assessments and recommendations
• Participates in companies internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
• Provides support to company Legal for product liability litigation, as appropriate
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
• Leads a process improvement initiative within SMG.
• Contributes to advancement of methodology and process by generating new ideas and proposals for implementation
• Raises concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner;
• Trains, coaches and mentors scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
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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