Associate Director, Pharmacovigilance- FSP
About The Position
The Associate Director, Pharmacovigilance (PVG) ensures delivery of safety management services in accordance with company SOPs/WPDs, ICH guidelines, and regulatory requirements. The role works with managers and other departmental personnel, oversees function operations, and manages the activities of managers and other staff. It develops and maintains departmental SOPs/WPDs and contributes to long-range planning for new processes and staffing needs. The Associate Director prepares business proposals and client presentations and works frequently with Business Development and Bids and Contracts groups. The position oversees safety processes, resource utilization, scope of work, budgets, and contractual matters; supports departmental and company goals; ensures compliance; guides managers and project team members; and manages experienced professionals and associated personnel matters.
Requirements
- Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 10+ years.
- 5+ years of management responsibility.
- Proven leadership skills.
- Expertise in global regulatory requirements for adverse event reporting, ICH safety guidelines, and GCP.
- Knowledge of safety database management.
- Expertise in budgeting, forecasting, and fiscal management.
- Analytical skills and excellent oral and written communication skills.
- Ability to handle multiple issues across multiple projects simultaneously.
- Ability to maintain a high degree of independence in decision-making and problem-solving.
- Ability to act as a liaison with other divisions to complete contract and regulatory requirements.
- Strong negotiating skills.
- Ability to analyze and evaluate processes and procedures.
Responsibilities
- Oversee department operations, including safety processes, resource utilization, scope of work, budgets, and contractual issues.
- Develop processes and strategies to help meet departmental and company goals.
- Oversee compliance with relevant company policies, procedures, and global regulations.
- Guide managers and train project team members as appropriate.
- Assist business development, foster client relationships, and deliver client presentations to help secure new business and retain existing business.
- Review and provide operational input on budgets, proposals, contracts, and renewals for existing clients.
- Manage experienced staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
- Approve courses of action related to salary administration, hiring, corrective action, and terminations.
- Review and approve time records, expense reports, leave requests, and overtime.
- Develop and maintain departmental SOPs/WPDs and contribute to long-range planning for processes and staffing.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
