Associate Director, Pharmacovigilance- FSP

Thermo Fisher Scientific • Chapel Hill, NC

1d

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 staff. It develops and maintains departmental SOPs/WPDs and plans for future processes and staffing needs. The Associate Director also prepares business proposals and client presentations and frequently interacts with Business Development and Bids and Contracts groups.

This position oversees departmental safety processes, resource utilization, scope of work, budgets, and contractual issues; develops processes and strategies to support department and company goals; and ensures compliance with relevant company policies, procedures, and global regulations. It guides managers and trains project team members as appropriate, supports business development and client relationships, and provides operational input on client budgets, proposals, contracts, and renewals.

The role manages experienced professionals and may oversee hiring and selection, professional development, performance management, coaching, counseling, salary administration, corrective actions, and separations. It also reviews and approves time records, expense reports, leave requests, and overtime. The work schedule is standard Monday through Friday, and the stated environmental condition is an office.

Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Experience providing the knowledge, skills, and abilities to perform the job, comparable to 10 or more years.
• Five or more 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.
• Ability to handle multiple issues across multiple projects simultaneously.
• Ability to make decisions and solve problems with a high degree of independence.
• 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.
• Support business development, foster client relationships, and present to clients 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, preparing job descriptions, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
• Approve courses of action involving 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 plan for new processes and staffing needs.
• Prepare business proposals and client presentations and interact with Business Development and Bids and Contracts groups.

Benefits

• The company supports and encourages employees to create a healthy and balanced environment where they can thrive.
• The company describes collaboration and development as part of the everyday work experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Director