Vice President Or Head Of Drug Safety And Pharmacovigilance

Position Overview:

Scorpion Therapeutics is seeking a highly experienced and strategic Vice President or Headof Drug Safety and Pharmacovigilance to lead our Safety and Pharmacovigilance efforts. Reporting directly to the Chief Medical Officer, the Vice Presidentof Drug Safety and Pharmacovigilance will be responsible for overseeing all aspects of Drug Safety, risk management, and Pharmacovigilance activities across our portfolio of oncology therapeutics.

Key Responsibilities:

• Develop and implement the strategic vision, goals, and objectives for Drug Safety and Pharmacovigilance in alignment with corporate objectives and regulatory requirements.
• Provide leadership and guidance to the Drug Safety and Pharmacovigilance team, fostering a culture of excellence, collaboration, and innovation.
• Lead the design, implementation, and execution of comprehensive safety surveillance and risk management plans for all stages of Drug development, from preclinical to post-marketing.
• Monitor and analyze safety data, adverse event reports, and safety signals to identify potential risks and implement risk mitigation strategies as needed.
• Ensure compliance with global regulatory requirements and guidelines related to pharmacovigilance and Drug Safety.
• Serve as the primary point of contact for regulatory agencies regarding safety-related inquiries, submissions, and inspections.
• Collaborate closely with clinical development, medical affairs, regulatory affairs, quality assurance, and other functional areas to integrate safety considerations into all stages of Drug development.
• Provide safety expertise and support to clinical development teams, including review and interpretation of safety data, protocol development, and safety-related documentation.
• Establish and maintain robust pharmacovigilance systems, processes, and procedures to ensure high-quality and compliant safety data collection, evaluation, and reporting.
• Conduct regular audits and assessments to evaluate the effectiveness of pharmacovigilance activities and identify areas for continuous improvement.

Qualifications:

• Advanced degree in pharmacy, medicine, life sciences, or related field. MD, PharmD, or PhD preferred.
• Minimum of 10 years of experience in Drug Safety and Pharmacovigilance within the pharmaceutical or biotechnology industry, with progressive leadership responsibilities.
• In-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices.
• Proven track record of successful leadership and management of pharmacovigilance teams and activities.
• Strong analytical skills, with the ability to interpret complex safety data and make data-driven decisions.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.