Safety Reporting Coordinator

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 the manager to any quality or timeline issues.
• Ensures timely maintenance of safety reporting systems and information.
• Liaises with various departments and extenal 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 with regulatory requirements.
• Shares ideas and suggestions with team members ensuring effective communication and participating 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, KPIs for projects.

Qualifications:

Education and Experience:

• Bachelor’s Degree
• 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 to 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 prioritize tasks simultaneously along with handling numerous deadlines and stay focused during these times
• Ability to work under pressure without jeopardizing work standards
• Ability to interact effectively with all levels of the organization
• Possess the maturity to handle sensitive information and data effectively
• Strong knowledge of procedural documents with the ability to identify gaps in processes and offer constructive suggestions for solutions
• Strong attention to detail
• Strong organization and time management skills with proven ability to handle multiple tasks at once and deal effectively with pressure
• Ability to apply knowledge, skills, and expertise to assist other colleagues in safety reporting activities