Job Description

Job Summary

The Senior Manager/Associate Director of Pharmacovigilance (PV) will oversee the pharmacovigilance activities for our clinical programs. This role is critical in ensuring the safety of our investigational compounds by managing adverse event reporting, signal detection, risk management, and compliance with global regulatory requirements. The successful candidate will lead a team of PV professionals, collaborate cross-functionally, and contribute to the strategic direction of the PV department.

Key Responsibilities

• Safety Monitoring and Reporting:
• Oversee the collection, evaluation, and reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials.
• Ensure timely submission of safety reports (e.g., Individual Case Safety Reports [ICSRs], Aggregated Safety Reports such as Development Safety Update Reports [DSURs]) to regulatory authorities (FDA, EMA, etc.).
• Implement and maintain robust pharmacovigilance systems and processes to ensure data integrity and compliance.
• Signal Detection and Risk Management:
• Lead signal detection activities, including data analysis and evaluation of safety signals to identify potential risks associated with company compounds
• Develop and implement Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) as required.
• Collaborate with clinical development teams to integrate safety findings into study protocols and regulatory submissions.
• Team Leadership and Management:
• Manage, mentor, and develop a team of pharmacovigilance professionals, fostering a culture of excellence and accountability.
• Oversee vendor management for outsourced PV activities, ensuring quality and compliance with service-level agreements.
• Allocate resources effectively to meet departmental goals and project timelines.
• Regulatory Compliance:
• Ensure compliance with global pharmacovigilance regulations, including ICH guidelines, FDA, EMA, and other regional requirements.
• Prepare for and participate in regulatory inspections and audits, addressing findings and implementing corrective actions as needed.
• Stay current with evolving PV regulations and industry best practices, incorporating updates into company processes.
• Cross-Functional Collaboration:
• Work closely with Clinical Development, Regulatory Affairs, and Quality Assurance teams to support product development.
• Provide safety expertise for clinical study reports, investigator brochures, and labeling documents.
• Represent the PV department in cross-functional meetings and contribute to strategic decision-making.
• Training and Process Improvement:
• Develop and deliver pharmacovigilance training programs for internal staff and external partners.
• Identify opportunities for process optimization and implement innovative solutions to enhance PV operations.

Qualifications

• Education:
• Advanced degree (PharmD, MD, PhD, or equivalent) in a life sciences or healthcare-related field. A Master’s degree with significant relevant experience may be considered.
• Experience:
• Minimum of 7-10 years of experience in pharmacovigilance within the biotechnology or pharmaceutical industry, with at least 3 years in a leadership or managerial role.
• Proven track record in managing safety reporting, signal detection, and risk management for clinical and/or marketed products.
• Experience with global regulatory requirements and submissions (e.g., FDA, EMA, PMDA).
• Prior involvement in regulatory inspections and audits is highly desirable.
• Skills and Competencies:
• Strong knowledge of pharmacovigilance principles, regulations, and guidelines (e.g., ICH, GVP, CFR).
• Excellent leadership and team management skills, with the ability to motivate and develop staff.
• Analytical mindset with proficiency in safety database systems (e.g., Argus, ARISg) and signal detection tools.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively across functions and with external stakeholders.
• Detail-oriented with strong organizational and project management abilities.
• Ability to work in a fast-paced environment and manage multiple priorities.

Preferred Qualifications

• Experience in developing small molecule and biologics in degenerative diseases.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Certification in pharmacovigilance (e.g., Drug Safety and Pharmacovigilance Certificate) is a plus.

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