Global Safety Lead
Our client is a global biotherapeutics company. They have asked us to assist them in a search for a Global Safety Lead.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees safety management teams.
- Oversees analysis of aggregate safety data.
- Supports the development of safety materials for FIH presentations.
- Ensures timely production of aggregate reports and answers to queries from Health Authorities.
- Participates actively in the Continuous Improvement Process.
- Reviews and contributes to safety relevant SOP and improvement of safety relevant SOPs.
- Is responsible for responses to Regulatory Agency requests.
- Ensures inspection findings are addressed and resultant Corrective Action Plans are implemented efficiently and effectively.
- Sets safety strategy based on knowledge and experience.
- Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents.
- Oversees development of core safety information for new products.
- Sets the strategy, reviews, and approves key filing documents.
- Provides contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk.
- Provides drug safety expertise and medical advice and provides strategic input in license agreements.
- Performs structured benefit-risk assessments for products across the therapeutic area portfolio.
- Applies analytical skills and knowledge about tools and approaches to collect, critically appraise, and integrate information from all relevant sources for benefit-risk management.
- Identifies literature sources and specifies search terms/filters for the identification and evaluation of signals.
- Incorporates RWE into signal identification and signal assessment.
- Prioritizes and escalates signals to the appropriate level in the organization.
- Evaluates signals for causality.
- Monitors and manages signals across the product lifecycle.
- Predicts potential risks and drafts risk mitigation strategies based on preclinical data.
- Develops and executes risk mitigation and minimization strategies across the product lifecycle.
- Selects and uses appropriate tools to evaluate the effectiveness of risk minimization and mitigation measures.
- Contributes to the onboarding and mentoring of other member of the global team around a clear set of standards and strategic objectives.
- An MD or international equivalent plus accredited residency is required.
- At least 2 years of working experience as a physician in patient care is required.
- Must have 10 years pharmaceutical or biotechnology industry experience, of which at least 5 should be in a safety role.
- Must have knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state.
- An understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials is required.
- Must understand key manufacturing aspects relevant to the safety of own portfolio.
- Must understand structure, key stakeholders, and interdependencies of the PV system.
- An understanding of the business environment of a pharmaceutical company and how safety decisions can impact other functions and patients is required.
- Must understand PV concepts, PV documents, and safety sections of documents.
- An understanding of product development process, the relevant scientific principles, and roles of contributing functions is required.
- Must understand relevant regulations and key regulatory milestones to have an open dialogue with Health Authorities.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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