Regulatory Compliance Manager overseeing compliance matters for a leading international financial institution. Ensuring alignment with regulatory requirements across corporate and investment banking businesses in an international environment.
SH
Hybrid Senior Safety & PV Operations Specialist – SPVG Regulatory Intelligence
Posted last week
About the role
- Senior Safety & PV Operations Specialist providing support to Safety and Pharmacovigilance. Identifying and maintaining worldwide regulatory requirements and serving as a subject matter expert in pharmacovigilance.
Responsibilities
- Provides support to the Safety and Pharmacovigilance organization by identifying, assessing, tracking, and maintaining worldwide regulatory requirements and trends related to end-to-end pharmacovigilance activities.
- Responsible for maintaining SPVG Regulatory Intelligence within the Regulatory Intelligence System.
- Contributes, reviews and drafts information for training materials, RI proposals and RI quality & compliance.
- Direct responsibility for conducting surveillance and research for assigned regulatory intelligence searches for specific countries within defined timeframes.
- Serves as a subject matter expert in pharmacovigilance regulatory requirements.
Requirements
- Bachelor's degree in life science, registered nurse, pharmacist, law or equivalent combination of education and experience.
- Experience in a clinical research organization preferred with a minimum of five (5) years' Safety and Pharmacovigilance experience across multiple roles.
- In depth understanding of clinical trial process across Phases II-IV and post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.
- Ability to work independently and in a team environment.
- Ability to successfully prioritize and work on multiple tasks and projects.
- Excellent communication, presentation, interpersonal skills, both written and spoken.
- Strong organizational and documentation skills.
- Detail oriented with a high degree of accuracy and ability to meet deadlines.
- Able to make effective decisions.
Benefits
- Health insurance
- Total rewards program
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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