Associate Director/Director - Pharmacovigilance Workstream Lead

Job Purpose

Overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team. Ensuring compliance with regulatory requirements, driving continuous improvement initiatives, and fostering cross-functional collaboration to enhance drug safety and minimize risks associated with pharmaceutical products.

Main tasks

• Workstream Leadership: 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
• Determine 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
• Generate 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

Key Performance Indicators

• Attainment of yearly goals according to Overall responsibility for delivering goals according to client agreement
• Effective and transparent communication and working relationships with client and workstream team members
• Evaluate and assess the results of the workstream with review of available metrics and KPIs, resource updates, and budgets

Regulatory Compliance

• 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

Cross-Functional Collaboration

• 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

Quality Assurance and Process Improvement

• 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
• At client and the local regulatory authority

Qualifications

The ideal candidate should have:

• A strong background in pharmacovigilance, clinical trials, and regulatory affairs
• Proven leadership skills and experience in managing cross-functional teams
• Excellent communication and interpersonal skills
• Strong analytical and problem-solving skills
• Experience with pharmacovigilance software and tools
• Knowledge of relevant regulatory frameworks and guidelines

Skills

• Pharmacovigilance
• Regulatory Affairs
• Leadership
• Communication
• Problem Solving
• Software Tools
• Regulatory Frameworks

Benefits

Our company offers:

• Competitive compensation package
• Flexible working hours
• Professional development opportunities
• Health and wellness programs
• Employee discounts

Pay

Salary range: $80,000 - $120,000 per year

Schedule

Full-time position, 40 hours per week