Drug Safety Specialist - GPV [Remote]

Job Responsibilities:

• Communicates with internal and external parties on case content and replies to case-related queries.
• Makes decisions on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc.
• Initiates case corrections, as needed.
• Approves case corrections, as needed
• Supports late case investigations by PV COPE team
• Performs clinical open query investigations
• Provides support for the creation/update of training materials in collaboration with the Data Assurance Manager and PV Training team.
• Assists in facilitating finalized training sessions (PV processes and systems) for vendors and relevant case processing staff in collaboration with the Data Assurance Manager and PV Training team.
• Provides support to global Data Assurance teams and other internal departments, as appropriate

Skills:

• 5+ years relevant experience within Pharmacovigilance
• Knowledge and understanding of PV regulatory requirements and ICSR processing procedures globally and in America’s region
• Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
• Present solutions to problems that require the regular use of creativity and ingenuity, while safeguarding Client’s compliance.
• Ensures case processing and case quality are maintained at highest standards at all times
• Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
• Good communication skills in English (written and spoken)
• Ability to work independently in seeking materials needed for completing daily tasks.
• Ability to work in a fast-paced environment.
• Working knowledge of ARGUS safety database
• Experience with Word, Excel, PowerPoint, Microsoft Teams and SharePoint sites
• Experience with working from home

Education/Experience:

• BS/MS degree in life sciences or equivalent (RN preferred)