Job Description
FULLY REMOTE
RESPONSIBILITIES:
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
RESPONSIBILITIES:
- May participate as the clinical safety representative on product development subteams
- Ensure relevant literature systematic review to collect AEs in local journal and/or for local marketed products not included in the global literature search
- Reporting safety information to the Global Drug Safety and local regulatory authority within specified timelines
- Maintain oversight of safety risk management and all other pharmacovigilance (PV) activities across all affiliate functions
- Ensure constant compliance to the local and global Standard Operating Procedures
- Acts as a safety representative and facilitator between external reporting sources
- Assist in responding to queries from health authorities or outside sources
- Management and submission of Individual Case Safety Report from all Spontaneous and Solicited sources
- Bachelor's degree in Medicine
- PharmD degree preferred
- 5+ years of medical monitoring experience
- Pharma, chem, or immunology background
- Experience with late phase trials
- PV oncology background preferred
- Proficient in Computer System Validation (CSV)
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.