Job Title: Pharmacovigilance Specialist
Duties: The Specialist, Pharmacovigilance (PV) supports the complaint handling processes to ensure compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc..) as described in the SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. Performs data quality review of adverse events for products manufactured or sold in the US.
Hybrid; 3 days onsite in either St. Joseph, MO or Duluth, GA
Shift Daytime
Hours 8am-5pm CST M-F
Supports the complaint handling processes to ensure compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc..) as described in the corporate PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. Performs data quality review of adverse events for products manufactured or sold in the US and/or global markets.
Assists with other regulatory duties as requested.
Skills:
Experience Experience in veterinary medicine and/or Pharmacovigilance experience preferred
Skills:
Experience working with Microsoft Office products and databases.
Must have excellent organization and time management skills.
Strong communication skills are required in order to work with diverse cultures and multiple -departments.
Ability to work in a team environment or experience working on project teams.
Ability to manage conflict and provide solutions to balance business needs with user friendliness.
Experience working within regulated pharmaceutical and/or biological industry environments preferred.
Occasionally may need to be flexible with working with team members in different time zones.
Experience working in a GMP/compliance environment subject to authority inspections preferred(FDA, USDA, EMA etc...).
Ability to remain calm under pressure and work to meet strict regulatory timelines.
|
Click here for technical assistance.
.jpg)
