Associate Safety Reporting Manager,

At Thermo Fisher Scientific, you’ll 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.

Discover Impactful Work:

Oversees and coordinates contracted safety responsibilities for one or more PVG programs, including staffing, training, and procedural compliance where safety reporting staff have reporting responsibilities.  Manages the safety reporting team on respective programs to ensure compliance and budget awareness. Works with senior management, and develops consistent internal processes and ensures compliance with established processes. Provides support and input for project metrics including compliance, hours and utilization. Proactively liaises with the Project Manager, clinical teams (where applicable) and clients and ensures optimal performance and utilization of the safety reporting team. Supports with project bidding, start up, monitoring and close out activities as needed for the project and where the contract requires. Coordinates, and ensures delivery for, complex global projects.

A day in the Life:

• Coordinates, manages and oversees operations of PVG safety reporting staff which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations

• Approves courses of action on salary administration, hiring, corrective action, and terminations. 

• Reviews and approves time records, expense reports, requests for leave, and overtime.

• Plans, organizes, manages and coordinates multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements, safety study start-up activities, study maintenance and study close out activities.

• Analyzes safety management costs, personnel hours, and project needs ensuring budget management adherence and business metrics captured.

• Coordinates business continuity activities as requiredin the event of system downtime, adverse weather or disaster.

• Maintains good communications with clients, other functional groups and PVG operational Senior Management concerning programs and/or company issues. 

• Serves as a resource to other departmental managers and leads departmental initiatives and collaborates with other employees in problem solving and systems improvement.

• GD and SOP writing and development.

• Interacts frequently with internal personnel and outside representatives at variouslevels.  Participates and presents at meetings with internal and externalrepresentatives.  Interaction typically concerns resolution of operational and process issues.

Keys to Success:

Specific Knowledge, Skills, and/or Abilities:

• Excellent communication skills in English including oral, written, and interpersonal• Ability to act as a liaison with clients, vendors, senior management and other divisions and represent PVG on interdepartmental working groups to achieve corporate directives and goals and their implementation• Proficient IT skills to include: MS Office (Word, Excel, PowerPoint, Access) and the ability to create and design reports; understanding, knowledge of safety databases• Proven ability to prioritize and handle multiple tasks simultaneously, to meet rigorous timelines and work effectively in stressful situations• Strong attention to detail and accuracy• Advanced critical thinking, problem solving and decision making skills• Ability to manage, motivate, mentor and supervise a diverse team and utilize the talents and abilities of all administrative direct reports• Knowledge of medical and safety terminology• Ability to effectively delegate tasks and follow-up on adequate completion• Expertise in budget management and metrics and resource allocations• Excellent knowledge of PPD procedures and processes including the importance of and compliance with procedural and regulatory requirements