Job Description
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)
Job Tags
Remote job, Work from home,