Safety Data Lead I

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.

Responsibilities

• 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.

Requirements

• 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.
• 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.

Additional location(s) Compensation Information

Required Skills: Data Processing, Data Quality Assurance, Data Review, Data Validation, English Language, Japanese Language, Pharmacovigilance Preferred Skills: Data Management, Japanese to English Translation, Quality Management Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/30/2027 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.