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Safety Reporting Coord

hace 4 meses

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo
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 team members 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 tasks.

At PPD, we hire the best, develop ourselves and each other, and recognise the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:
Provides administrative safety support to the safety reporting team and Pharmacovigilance department.

Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department's projects.

Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects.

Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues.

May also be involved in updates to procedures and other initiatives related to safety reporting.

May mentor or train new central safety reporting staff.

Essential Functions:

  • Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation.
  • Assists in producing metrics and alerts manager to any quality or timeline issues.
  • Ensures timely maintenance of safety reporting systems and information.
  • Liaises with various departments and external parties (including clients) in relation to safety reporting tasks and the setting up and maintenance of projects.
  • Good understanding of SOPs, GDs and project related documentation.
  • Proactively troubleshoots daily operational issues with limited input from management.
  • With support of management, provides updates to the operational safety reporting team and Senior Management in relation to work deliverables / status as required and in accordance to regulatory requirements.
  • Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
  • Responsible for training Pharmacovigilance department staff on the safety reporting process and various systems associated with safety reporting.
  • Assists with, and may participate in, audit and inspection preparation if required or requested by the company or client.
  • Knowledge of, and ability to perform against, critical metrics for projects. Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

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.

Knowledge, Skills and Abilities:

  • Ability to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks
  • Ability to work effectively as an individual and independently to attain the wider goals of the team.
  • Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint)
  • Good knowledge of Pharmacovigilance and industry terminology
  • Strong written and verbal communication skills, including telephone conversations as well as face to face interaction internally within the department
  • Ability to identify and prioritise tasks simultaneously along with handling numerous deadlines and stay focused during these times
  • Ability to work under pressure without jeopardising work standards
  • Ability to interact effectively with all levels of the organization
  • Possess the maturity to handle sensitive information and dat