Manager, Pharmacovigilance

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.

Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.

As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.

Discover Impactful Work:

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.

A day in the Life:

• Manages multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
• Maintains good communications with other functional groups concerning program and company issues. Collaborates with other employees in problem solving and systems improvement.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
• Maintains a basic medical understanding of applicable therapeutic area and disease states. May participate on-call duties for specific projects and ensures 24-hr coverage for intake of cases from investigative sites.
• Provides plans and accurate forecasts for all projects.
• Serves as a resource to other departmental managers and leads departmental initiatives.
• Prepares and presents proposals.
• 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.

Keys to Success:Education

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• 1+ year of leadership responsibility

Knowledge, Skills, Abilities

• Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents
• Strong knowledge of relevant therapeutic areas as required for processing AEs
• General knowledge of pathophysiology and the disease process
• Time management and project management skills
• 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

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. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

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.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

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