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 Global Pharmacovigilance Case Management (GPVCM) 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, Global Pharmacovigilance Case Management (GPVCM) 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.
#R402159
Required Skills:
Data Processing, English Language, Ensure Compliance, Japanese Language, Pharmacovigilance, Regulatory Requirements
Preferred Skills:
Adverse Drug Reaction (ADR) Monitoring, ADVERSE DRUG REACTION (ADR) Reporting, Adverse Drug Reactions, Drug Safety Surveillance, Drug Stability
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Search Firm Representatives Please Read Carefully Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; 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. &nbsp;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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
12/31/2026
*A job posting is effective until 11:59:59PM on the day BEFORE&nbsp;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.

Safety Data Lead I

Safety Data Lead I

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