Piney Technical Services
Data Specialist, Pharmacovigilance
Piney Technical Services, Saint Joseph, Missouri, United States
Full-Time/Part-Time
Full-Time
Description
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.
Location St. Joseph, MO
This position is currently accepting applications.
Description
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.
Location St. Joseph, MO
This position is currently accepting applications.