Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Responsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department's projects. Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues. Leads projects and programs and provides guidance and support to other team members. May also be involved in updates to procedures, regulatory intelligence activities and other initiatives related to safety reporting.

Essential Functions and Other Job Information:

Essential Functions

Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. Provides input and feedback to aid the development of program and departmental procedural documents. Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions. Liaises with relevant departments around safety reporting tasks and attends various meetings as required. Provides input, feedback and guidance to other team members and mentors new starters. Produces metrics and has some involvement in financial project.

Job Knowledge

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

Business Relationships

Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.

Qualifications:

Education and Experience:


Bachelor's degree or equivalent and relevant formal academic / vocational qualification.


Previous experience provides the knowledge, skills, and abilities to perform the job (comparable to 3+ 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:

Excellent knowledge of medical terminology Excellent Microsoft Office skills and good understanding of database functionality Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements Good time management and multi-tasking skills Strong attention to detail Ability to influence at all levels of the organization Ability to work well in a collaborative team environment Demonstrated initiative and utilizes persuasion and negotiation skills Excellent critical thinking and problem-solving abilities * Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities