Sr Safety Admin

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

This remote-based role where we maintain high standards. You will join a cooperative team committed to achieving excellence and ambitious goals.

How Will You Make an Impact:

As a Drug Safety Admin Associate III you will have an integral part in ensuring the safety and efficacy of our products. Your meticulous attention to detail will help us successfully implement safety measures and compete in a global market.

A Day in the Life:

• Conducting data entry and analysis for safety reports
• Coordinating with cross-functional teams to determine safety protocols
• Coordinating the timely review of protocol inquiries triage of abnormal lab alerts and diagnostics tracking all necessary data and generating reports for the client project team and/or external vendors.
• Identifies and redacts subject identifiers per local requirements; retraining sites and escalates reoccurrences to PPD Data Privacy.
• Manages project specific training in collaboration with the project lead/manager PV Lead and the Project specific training team including the application of training within the learning management system.
• Performs data entry into tracking systems and performs system reconciliations to identify issues which may negatively impact project timelines.
• Coordinates and facilitates project and/or client meetings drafts meeting minutes posts to client portals and distributes to internal and external project teams.
• Manages the set-up maintenance and archival of program files within PPDs electronic filing system.
• Liaises with various internal function groups to implement projects ensuring contractual obligations are met and timelines are achieved.
• Supports any specific activities performed by the local office which cannot be performed from elsewhere.
• Job Complexity - Works on assignments that are routine in nature requiring limited judgment. Has little or no role in decision-making.
• Job Knowledge - Acquires job skills and learns company policies and procedures to complete routine tasks.
• Acts as Subject Matter Expert for one or more PV processes and/or systems
• Business Relationships - Contacts are primarily within the immediate work unit. Contacts involve obtaining or providing information requiring little explanation or interpretation.
• Mentors junior staff.
• Works on assignments that are moderately difficult requiring judgment in resolving issues or in making recommendations.
• Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks.
• Normally receives little instruction on daily work general instructions on newly introduced assignments.
• Contacts are frequent with individuals representing other departments and / or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function or the department or which may be of a sensitive nature.

Experience:

Band III (Administrative):

Education and Experience:

• Preferred: Experience in administrative roles particularly in healthcare or pharmaceutical settings
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to at least 4 years).
• 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:

• Ability to assist in the management of a large project and to provide work direction and training to other safety support staff working on the project
• Strong critical thinking skills and ability to use problem-solving techniques applicable to constantly
• changing environments
• Ability to work independently with minimal supervision demonstrating initiative
• 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 the organizations/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation execution and closeout

Physical Requirements / Work Environment

Working Conditions and Environment:

• Ability to sit or stand for extended periods
• Work is performed in an office environment with exposure to electrical office equipment
• Majority of work computer-based

Physical Requirements:

• Frequently stationary for 4-6 hours per day
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists
• Occasional mobility required
• Occasional crouching stooping bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf

What We Offer

Compensation

• Competitive Annual Pay Rate
• Performance Related Bonus where eligible*
• Annual merit performance-based increase

Excellent Benefits

• Medical Benefits*
• Annual Leave
• Pension Plan*
• Employee Referral Bonus
• Career Advancement Opportunities
• This may vary by country based on local legal requirements.