Position Title: Global Pharmacovigilance Specialist
Work Location: Remote
Assignment Duration: 12 Months
Work Arrangement: Remote
Key Responsibilities:

• Communicates with internal and external parties on case contents, and to reply to related queries
• Makes first line decisions on case processing matters for prioritization, FU significance, seriousness, labeling, coding queries, etc
• Performs or initiates case corrections, as needed
• Performs SME services for ICSR processing queries by the vendor
• Supports late case investigations by the regional PV Case Management team.
• Provides Subject Matter Expertise (medical/technical.) for the creation of training materials in collaboration with the PV Training team.
• Facilitates finalized training sessions (PV Processes and systems) for vendors and PV Process staff in collaboration with PV Training team. Qualification Experience:
• MS degree in life sciences or equivalent (RN preferred)
• 5+ years relevant experience; ICSR case processing (PV case processing) and expertise within Pharmacovigilance
• In-depth knowledge and understanding of PV Process regulatory requirements and ICSR processing procedures globally and in Americas region
• A technical expert within the organization, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines. Has the ability to recommend enhancements to internal policies,
• processes and procedures based on new requirements, legislation, etc.
• Provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding our organization'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)

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 52.00/hr.