Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 II, 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 reportsCoordinating with cross-functional teams to determine safety protocolsCoordinating 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 natureJob Knowledge – Applies acquired job skills and company policies and procedures to complete routine tasks.Business Relationships - Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.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.

Experience:

Band II (Administrative):

Education and Experience:

Preferred: Experience in administrative roles, particularly in healthcare or pharmaceutical settingsHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 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:

Strong problem-solving skillsAbility to work independently with minimal supervision, demonstrating initiativeAbility to build strong relationshipsAbility to effectively analyze project-specific data/systems to ensure accuracy and efficiencyAbility to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staffSelf-motivated, positive attitude with effective oral and written communication and interpersonal skillsExcellent 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 deadlinesStrong attention to detail and accuracy with orientation toward careful and meticulous workAbility to maintain a positive and professional demeanor in challenging circumstancesFlexibility to reprioritize workload to meet changing project timelinesDemonstrated 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 periodsWork is performed in an office environment with exposure to electrical office equipmentMajority of work computer-based

Physical Requirements:

Frequently stationary for 4-6 hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wristsOccasional mobility requiredOccasional crouching, stooping, bending and twisting of upper body and neckLight 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 RatePerformance Related Bonus where eligible*Annual merit performance-based increase

Excellent Benefits

Medical Benefits*Annual LeavePension Plan*Employee Referral BonusCareer Advancement OpportunitiesThis may vary by country based on local legal requirements.