We are seeking an experienced Manager, Safety & Pharmacovigilance (ICSR) to lead and oversee the pharmacovigilance team. This role is responsible for ensuring the timely and accurate submission of reports related to individual case safety reports (ICSRs) and other safety reporting documents. The ideal candidate will have a strong background in pharmacovigilance, proven people management skills, and a deep understanding of global drug regulations and safety databases.
Roles & Responsibilities
- Leadership and People Management:
- Serve as a line manager for the team, handling responsibilities such as hiring, training, performance appraisals, and employee counseling.
- Advise staff on administrative policies, technical issues, and task prioritization.
- Assign and review project workloads for direct reports.
- Provide oversight and guidance on organizational and company objectives.
- Mentor team members and manage resource needs and issues.
- Project and Financial Management:
- Manage projects where Safety and Pharmacovigilance are the primary services.
- Review study budgets and expenses to ensure all contractual and budgeting issues are upheld.
- Approve project time cards and invoicing, and work with the Finance department to ensure appropriate client invoicing.
- Provide sponsors with regular project updates and reports.
- Compliance and Quality Assurance:
- Monitor the quality and efficiency of the team's work, ensuring compliance with the scope of work and Safety Management Plan.
- Assist in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
- Maintain and ensure compliance with SOPs, Work Instructions (WIs), global drug regulations, GCPs, ICH guidelines, and GVP modules.
- Participate in audits and inspections, and ensure a state of inspection readiness.
- Interdepartmental Collaboration and Business Development:
- Coordinate with other internal departments to ensure timely review and submission of safety reports.
- Represent the department at project team meetings and client meetings.
- Work with Business Development to actively solicit new business and participate in bid defense meetings.
- Review and approve the safety portions of project proposals to ensure they accurately reflect the scope of work.
Qualifications
- Professional experience in pharmacovigilance with a background in people management.
- A BA/BS in the biological sciences or a related field, or an equivalent combination of education and experience.
- Excellent MS Excel skills.
- Experience with ARGUS / ARISg Safety Databases is preferred.
- Knowledge of SQL / Power BI is a plus.
- Proven experience with progressive responsibility, demonstrated leadership, and project management skills.
- Clinical Research Organization (CRO) experience with therapeutic specialties is preferred.
- A working knowledge of financial budgets and various financial analysis tools is preferred.
- Excellent oral, written, and interpersonal communication skills.
- The ability to be flexible, adapt to change, and manage multiple priorities while delivering high-quality work.
