Salary$105 - $115 per hour
- Regularly review results of all available data from external and internal sources, spontaneous adverse event reports, and cumulative data from non-spontaneous (solicited) sources, provide medical clinical expertise for causality assessments and reporting of data and assessment results to internal (e.g., SMT) and external stakeholders (e.g., Health Authorities)
- Provide documented medical safety input for product quality Communicate any safety signals /issues that have a potential quality component arising during evaluation of medical safety issues to Q&C or those without a quality component but may require market action to the QRB.
- Provide medical safety input and oversight of preparation of responses to safety- related queries from Health Authorities; make decision if initiation of a prompt communication to patients, health care professionals (e.g., Dear HCP letters), and HA is required and provide medical input to such communications
- Give strategic guidelines for how Consumer safety should support Medical Affairs; review framework for appropriate representation during safety-related regulatory inspections and internal quality assurance / corporate compliance audits; proactively provide strategic leadership role in organizational strategy, goals, and objectives for
- Ensure strategic insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols; oversee approval of safety-related content for press releases and other public and professional
- Responsible for applying industry-leading operational strategy and criteria for appropriate escalation of safety-related issues and remedying Provides final decision-making for rollout and implementation of new safety initiatives.
- Initiate escalation of safety signals/issues, including those requiring a field action, to the Consumer MSC and senior management as Coordinate with cross-functional team to prepare and present new product development programs to Consumer Medical Safety Council.
- Provide safety expertise and decisions to Labeling Working Groups (LWGs), including review and endorsement of new safety information in new/revised CCDS, in accordance with applicable
- Provide input into aggregate safety reviews and advise on the appropriate strategy for Benefit /Risk Evaluation, and participate in appropriate Risk Management activities (e.g., Product Risk Management).
- Minimum of 5 years of medical/clinical experience
- Minimum of 5 years of experience in pharmacovigilance and/or drug/device experience in medical safety Consumer sector or drug safety or development in Pharma and Medical Devices sector and safety inspections and understanding of global safety regulations preferred.
- Education: Physician (MD) with postgraduate training.
- Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance
- Experience in risk evaluation and mitigation
- Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory reports; experience in preparing RMPs, PSURs