Summary
The job is for an Associate Director/Director - Pharmacovigilance Workstream Lead. The role involves overseeing pharmacovigilance activities, ensuring compliance with regulatory requirements, driving continuous improvement initiatives, and fostering cross-functional collaboration to enhance drug safety.
Requirements
- Overall responsibility for delivering goals according to client agreement
- Ensures effective and transparent communication and working relationships with client and workstream team members
- Stay abreast of evolving regulatory requirements related to pharmacovigilance and ensure adherence to applicable regulations and guidelines (e.g., FDA, EMA, ICH)
- Collaborate with regulatory affairs teams to coordinate and submit pharmacovigilance-related documentation for regulatory authorities, including periodic safety reports and risk management plans
- Manage a state of always ready for inspection while participating in ongoing PV inspections and audits
- Work closely with other departments such as clinical development, medical affairs, and quality assurance to integrate pharmacovigilance activities into product development and lifecycle management processes
- Collaborate with external partners, including contract research organizations (CROs) and regulatory agencies, to facilitate pharmacovigilance-related activities and ensure timely execution of deliverables
- Integrate internal experts, the client and external partners into the pharmacovigilance activities
- Support audits, inspections and assessments of pharmacovigilance processes and systems to ensure compliance with quality standards and identify opportunities for improvement on behalf of the client
- Support the implementation of corrective and preventive actions (CAPAs) as necessary to address findings from audits, inspections, or internal reviews
Responsibilities
- Responsible and accountable for assigned workstream to ensure that overall workstream is within expected costs, resources, timelines and budget and meets expected quality standards according to defined client agreements and expectations
- Responsible for determining the pharmacovigilance activities scope and objectives, develop project plans and monitor progress
- Lead in the initial design and configuration of the global pharmacovigilance framework to accommodate a client's strategic needs
- Lead and manage pharmacovigilance activities within a specific workstream or therapeutic area, ensuring alignment with organizational objectives and regulatory standards
- Responsible for generating accurate and timely reporting of pharmacovigilance activities status to internal and external stakeholders
- Develop and execute strategic plans for pharmacovigilance activities, including signal detection, risk management, case processing, aggregate reporting, and safety surveillance, as well as operational plans for scaling to other geographic and therapeutic areas
- Provide guidance and mentorship to pharmacovigilance team members, fostering a culture of excellence and continuous improvement
