Associate Director, Pharmacovigilance- FSP

Work Schedule

Environmental Conditions

Job Description

Join Us as a Associate Director PV

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

The Associate Director PVG ensures the delivery of safety management services consistent with company SOPs/WPDs ICH guidelines and regulatory requirements. Works with managers and liaises with other departmental personnel as required. Oversees function operations and manages the activities of managers and other staff. Develops and maintains departmental SOPs/WPDs and long-range planning for new processes and staffing needs. Prepares business proposals and client presentations and interacts frequently with members of the Business Development and Bids and Contracts groups.

What Youll Do:

• Oversee effectiveness of department operations to include safety processes resource utilization scope of work budget and contractual issues
• Develop processes and strategies designed to assist in meeting departmental and company goals.
• Oversee compliance with all relevant company policies procedures and global regulations.
• Guide managers and train project team members as appropriate.
• Assist business development and foster client relationships and provide department business development presentations for clients to help secure new business as well as retain ongoing business for existing clients.
• Review and provide operational input on budgets proposals contracts and/or renewals associated with existing clients.
• Manage staff of experienced professionals which may include interviewing and selection job description preparation professional development goal setting performance management coaching and mentoring employee counseling and separations. Approve courses of action on salary administration hiring corrective action and terminations. Review and approve time records expense reports requests for leave and overtime.

Education and Experience Requirements:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 10 years).
• 5 years of management responsibility
• Proven leadership skills

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills Abilities:

• Expertise in global regulatory requirements for adverse event reporting ICH safety guidelines GCP etc.
• Knowledgeable of safety database management
• Expertise in budgeting forecasting and fiscal management
• Analytical skills as well as excellence in oral and written communications
• Ability to handle multiple issues on multiple projects simultaneously
• Know how to maintain a high degree of independence with respect to decision making and problem solving
• Ability to act as liaison with other divisions necessary to complete contract/regulatory requirements
• Strong negotiating skills
• Ability to analyze and evaluate processes and procedures

Working Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.

Required Experience:

Director