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该职位为药物警戒数据负责人，负责分析和解读不良事件报告，遵循法规要求与内部流程。在全球药物警戒案例管理经理监督下，执行调查中和上市产品的AE案例管理活动，与内外部利益相关方协作确保流程标准化与合规。
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 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 RequirementsPreferred Skills:
Adverse Drug Reaction (ADR) Monitoring, ADVERSE DRUG REACTION (ADR) Reporting, Adverse Drug Reactions, Drug Safety Surveillance, Drug StabilityCurrent 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
NAJob Posting End Date:
12/31/2026*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.
研究和试验发展
