Safety Data Lead I

Job Description

The Safety Data Lead is responsible for the analysis and interpretation of adverse experience (AE) reports of varying complexity, in compliance with regulatory requirements and internal processes. Working under the supervision of a Safety Data Management Manager, the Safety Data Lead executes AE case management activities for both investigational and marketed products in accordance with specific therapeutic area standards. Collaboration with internal and external stakeholders is essential to maintain high quality and timely execution of the processes.

Among other tasks, the Safety Data Lead is responsible for: 

• Performing analysis, interpretation, and data entry of adverse event reports from a wide range of sources and therapeutic areas, demonstrating increasing proficiency in clinical knowledge, Safety Data Management processes and regulatory guidelines.

• Providing support or leading operational activities appropriate to level of experience and expertise.

• Collaborating with internal and external stakeholders to resolve issues of varying complexity to guarantee process standardization and adherence and ensure compliance with reporting requirements.

• Supporting simplification and optimization of case management activities to enhance overall effectiveness.

Education and other Qualifications: 

• Bachelor’s degree or above in health care or life sciences disciplines.  

• Advanced writing/reading and intermediate speaking/listening English language skills. 

• Optional advanced writing/reading and intermediate speaking/listening other region-specific language skills. 

• Understanding of pharmacovigilance-related regulations is desired. 

Core Competencies:

• Decision Making: identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitive and qualitive information; choosing the best course of action by establishing clear decision criteria, generating, and evaluating alternatives, and making timely decisions.

• Business Savviness: understanding the business; building and applying knowledge of company and functional area operations, to improve individual, work group and/or organizational results.

• Networking & Partnerships: building partnerships; developing and leveraging relationships within and across work groups to achieve results.

• Strategic Planning: prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.  

• Motivation and Inspiration: Communicating effectively; conveying information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listening actively to others.

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