PV RA MW Coordinator

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:

Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards and Endpoint Adjudication Committees. In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all incoming safety documentation.

A day in the Life:

Job Description

• Provides critical support and coordination in the review of safety and regulatory publishing documents, ensuring timely and accurate processing upon receipt.
• Plays a key role in maintaining document quality by tracking safety and regulatory publishing data, ensuring seamless uploading into internal and/or external electronic trial master files.
• Takes responsibility for maintaining the confidentiality and integrity of sensitive information, meticulously ensuring the redaction of Commercially Confident Information and Personal Data for regulatory publishing.
• Assists in the maintenance of licenses across projects, ensuring compliance with IT Security standards and facilitating smooth operations for users.
• Takes charge of coordinating and facilitating project meetings, ensuring effective communication and collaboration among team members.
• Demonstrates exceptional organizational skills by managing project-specific training, setting up and maintaining program files, and ensuring audit readiness.
• Protects subject and client confidentiality by identifying and redacting confidential identifiers according to local requirements, providing necessary retraining, and escalating any recurring issues to PPD Data Privacy.
• Performs accurate and efficient data entry into various databases and tracking systems, including PPD's budget management system, ensuring project timelines are not compromised.
• Takes ownership of overseeing expenses and managing translations, ensuring adherence to budget parameters and cost-efficiency.
• Assists in the essential task of archiving regulatory publishing documents and submissions, contributing to the seamless flow of information and compliance

Keys to Success:

Education

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
• Knowledge, skills and abilities:
• Strong problem solving skills
• Ability to work independently with minimal supervision, demonstrating initative
• Ability to build strong relationships
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
• Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access)
• Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

Work 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.

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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.