Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries

Drug Safety Admin Associate II

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Location: Remote

Position Overview

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.

This remote-based role requires maintaining 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 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.
  • Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.

Job Knowledge

  • Applies acquired job skills and company policies and procedures to complete routine tasks.
  • Has substantial understanding of the job and applies knowledge and skills to complete a wide range of 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.

Experience

Band II (Administrative)

Education and Experience:

  • 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 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.

Preferred:

  • Experience in administrative roles, particularly in healthcare or pharmaceutical settings.

Knowledge, Skills, Abilities

  • Strong problem-solving skills.
  • 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.

Skills

Data Entry
Data Analysis
Safety Protocols
Report Generation
Data Privacy
Training Management
System Reconciliation
Attention to Detail
Coordination

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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