Drug Safety Admin Associate I

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you'll 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 world's 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 I, 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 PPD's 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.
• Supervision Received - Normally receives detailed instructions on all work. Works under close supervision.
• Business Relationships - Contacts are primarily within immediate work unit. Contacts involve obtaining or providing information requiring little explanation or interpretation.

Experience:

Band 1 (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 0 to 1 year).
• 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:

• Demonstrated organizational skills with an outstanding attention to detail
• Strong communication skills, both written and verbal
• 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
• Ability to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervision
• 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 organization's/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
• Potential drives to site locations and/or travel required on rare occasion
• 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.