Drug Safety Operations Manager

Work Schedule

Environmental Conditions

Job Description

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.

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.

• Monitors, evaluates, and proposes mitigation strategies surrounding risk to PV project deliverables and finances.
• Serves as key point of contact for client.
• Accountable for project financial stewardship and negotiates options with the client for various increases in scope of work to drive healthy gross profit and revenue margins.
• Drives timelines and tasks/deliverables for safety reporting PV functions
• Prepares and leads operational/tactical/governance calls with client(s).
• Coordinates and leads preparation and attendance in client audits/inspections.
• Maintains effective communication and coordination with other functional groupsconcerning project topics/issues.
• Oversees generation of project metrics (e.g., key performance indicators, volumes, etc.).
• Maintains budget/financial oversight of assigned project(s), working with applicable teams for contractual activities (i.e., change notification forms, contract modifications, renewals, etc.) for all PV services.
• Responsible for presenting on internal financial and project review meetings.
• Broad understanding of PV and regulatory requirements, along with contracted activities and project outputs.
• Accountable for collaboration with all PV functions to ensure key performance indicators meet agreed targets.
• Serves as a resource to other departmental managers and leads departmental initiatives.
• Manages 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. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

• Bachelors degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• 1+ year of leadership responsibility
• 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.

• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to relevant legislation/regulations/guidance, global SOPs and client expectations
• Broad understanding of PV along with working knowledge of the global regulatory requirements and the importance of procedural/process compliance
• Proficient in Microsoft Office products and safety databases
• Good command of English and ability to translate information into local language where required
• Excellent oral and written communication skills
• Strong attention to detail and accuracy
• Strong critical thinking, problem solving and decision-making skills

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.