Head of Drug Safety (Executive Director/VP)

*Non-local candidates encouraged to apply* 

Head of Drug Safety (Executive Director/VP)

Reporting to the President of R&D, the Head of Drug Safety will be responsible for leading the pharmacovigilance function, providing leadership and clinical support to drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).

Responsibilities:

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse events
• Address safety-related topics as a member of the Clinical Leadership Team
• Work with Medical Directors, CRO Safety Physicians, and Clinical Scientists on safety monitoring and assessment activities, including:
• Ensure that the all development team members understand the fundamental of pharmacovigilance, according to their roles in the organization, so they can understand and support, when needed, the PV-related activities
• Constant evaluation of the effectiveness of the Drug Safety system
• Oversight of the Drug Safety system(s) and when necessary communicate recommended changes to assure:
• Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
• Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
• Lead the development of and review DSURs with Medical Directors/Clinical Scientists
• Review safety sections on cross-functional documents, including study protocols, study reports, and regulatory reports
• Ensure audit and inspection readiness of the function at all times
• Enthusiastic team player that brings a positive attitude
• Strong listening skills to foster an open, collaborative environment

Qualifications:

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse events
• Address safety-related topics as a member of the Clinical Leadership Team
• Work with Medical Directors, CRO Safety Physicians, and Clinical Scientists on safety monitoring and assessment activities, including:
• Ensure that the all development team members understand the fundamental of pharmacovigilance, according to their roles in the organization, so they can understand and support, when needed, the PV-related activities
• Constant evaluation of the effectiveness of the Drug Safety system
• Oversight of the Drug Safety system(s) and when necessary communicate recommended changes to assure:
• Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
• Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
• Lead the development of and review DSURs with Medical Directors/Clinical Scientists
• Review safety sections on cross-functional documents, including study protocols, study reports, and regulatory reports
• Ensure audit and inspection readiness of the function at all times
• Enthusiastic team player that brings a positive attitude
• Strong listening skills to foster an open, collaborative environment
•