R&D PV Safety Risk Management Sr. Specialist

J-RMP（安全性検討事項、安全性監視計画）の立案、作成

CTDの関連パート作成、審査対応

J-RMPの改訂要否検討及び改訂案作成（PMDA、米国本社及び国内他社等との交渉／相談含む）

TOEIC 700点以上）

ITスキル（Word、Excel、PPTなど）

GCP、GVP、GPSP等安全性業務関連の国内外の規制に関する知識

Current Employees apply

Current Contingent Workers apply

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) :

Required Skills :

Adaptability, Adaptability, Adverse Event Report, Auditing, Communication, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, English Language, Hospital Medicine, Information Technology Applications, Marketing, Oncology, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Pharmacy, Problem Solving, Protective Security, Quantitative Abilities, Regulatory Compliance, Regulatory Reporting, Report Writing, Risk Management, Safety Procedures {+ 2 more}

Preferred Skills :

Job Posting End Date :

12 / 31 / 2025

• 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.

Requisition ID : R353376