TalentBurst
Pharmacovigilance Specialist
TalentBurst, Duluth, Georgia, United States, 30155
Title: Pharmacovigilance SpecialistLocation: StJoseph, MO 64506 or Duluth, GA 30096Duration: 12 MonthsShift: Hours – 8-5 M-F
Duties:This would be a site-based position and the candidate would be required to be on-site at one of the locations (Duluth or ST Joseph) a minimum of 2 days/week.
Basic purpose of the job:Ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc.)as described in the corporate and BIAH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations.Review, Assess and approve product/adverse event complaints for BIAH products manufactured or sold in the US, and submit to appropriate authorities as required.May provide support to Pharmacovigilance(PV)Management in the area of ADE analysis, PV trending and/or signal detection.
Duties:Supports Global PV management in maintaining compliance with regulatory requirements and BI procedures:-Manages a backlog of PV case reports originating from the EU Pharmacovigilance Database (Eudravigilance (EVVET)).-Together with assigned Specialists, imports cases directly from the EVVET into PV Works, and manage these case according to internal guidance and global regulatory requirements.-Reviews case information on individual case reports or line listings as requested by Management and/or LPVs-Update all import cases to meet BI standard of data-Reviews and evaluates all complaints for accurate and consistent data, coding and case assessments and submission to applicable regulatory authorities.-Works with all LPVs to ensure case processing meets OPU requirements.-Assists stakeholders with PV reports as requested.Independently applies basic scientific principles, performs literature searches, keeps abreast of literature in own field and attends scientific meetings; demonstrates a contemporary level of technical proficiency in field.
Skills:Lead & Learn & Leadership CompetenciesFunctional CompetenciesKnowledge of Pharmaceutical Life Cycle Process - Level 2, DemonstratingKnowledge of Regulatory Requirements & Compliance - Level 2, DemonstratingLeveraging strategic relationships – Level 1, Developing
Managing Conflict - Level 2, DemonstratingNegotiation Skills - Level 2, DemonstratingMarket knowledge - Level 2, DemonstratingCore CompetencesBusiness and Technical Knowledge - Level 2, DemonstratingCommunication - Level 2, DemonstratingCustomer Orientation - Level 2, DemonstratingDelivering Results - Level 2, DemonstratingExternal Focus - Level 1, DevelopingFast and Focused Execution - Level 2, DemonstratingInnovation and Change – Level 2, DemonstratingLives Lead & Learn - Level 2, DemonstratingPlanning & Organization - Level 2, DemonstratingQuality Orientation/Bus Process Excellence - Level 2, DemonstratingTeamwork and Collaboration - Level 2, DemonstratingWinning Vision – Level 1, DevelopingProblem Solving - Level 2, DemonstratingLeveraging Strategic Relationships - Level 2, DemonstratingContinuous Learning – Level 2, DemonstratingAnalytical Thinking - Level 2, DemonstratingFoundational CompetenciesAccountability and OwnershipIntegrity and TrustValues Diversity and Inclusion
Education:Minimum Education/Degree Requirements*Veterinary degree(DVM or VMD) required from an accredited veterinary school withThree (3) Years of veterinary practice experience or Pharmacovigilance,Pharmacoepidemiology or related field experience.Previous pharmaceutical industry or drug safety/pharmacovigilance experiencepreferred.
Duties:This would be a site-based position and the candidate would be required to be on-site at one of the locations (Duluth or ST Joseph) a minimum of 2 days/week.
Basic purpose of the job:Ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc.)as described in the corporate and BIAH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations.Review, Assess and approve product/adverse event complaints for BIAH products manufactured or sold in the US, and submit to appropriate authorities as required.May provide support to Pharmacovigilance(PV)Management in the area of ADE analysis, PV trending and/or signal detection.
Duties:Supports Global PV management in maintaining compliance with regulatory requirements and BI procedures:-Manages a backlog of PV case reports originating from the EU Pharmacovigilance Database (Eudravigilance (EVVET)).-Together with assigned Specialists, imports cases directly from the EVVET into PV Works, and manage these case according to internal guidance and global regulatory requirements.-Reviews case information on individual case reports or line listings as requested by Management and/or LPVs-Update all import cases to meet BI standard of data-Reviews and evaluates all complaints for accurate and consistent data, coding and case assessments and submission to applicable regulatory authorities.-Works with all LPVs to ensure case processing meets OPU requirements.-Assists stakeholders with PV reports as requested.Independently applies basic scientific principles, performs literature searches, keeps abreast of literature in own field and attends scientific meetings; demonstrates a contemporary level of technical proficiency in field.
Skills:Lead & Learn & Leadership CompetenciesFunctional CompetenciesKnowledge of Pharmaceutical Life Cycle Process - Level 2, DemonstratingKnowledge of Regulatory Requirements & Compliance - Level 2, DemonstratingLeveraging strategic relationships – Level 1, Developing
Managing Conflict - Level 2, DemonstratingNegotiation Skills - Level 2, DemonstratingMarket knowledge - Level 2, DemonstratingCore CompetencesBusiness and Technical Knowledge - Level 2, DemonstratingCommunication - Level 2, DemonstratingCustomer Orientation - Level 2, DemonstratingDelivering Results - Level 2, DemonstratingExternal Focus - Level 1, DevelopingFast and Focused Execution - Level 2, DemonstratingInnovation and Change – Level 2, DemonstratingLives Lead & Learn - Level 2, DemonstratingPlanning & Organization - Level 2, DemonstratingQuality Orientation/Bus Process Excellence - Level 2, DemonstratingTeamwork and Collaboration - Level 2, DemonstratingWinning Vision – Level 1, DevelopingProblem Solving - Level 2, DemonstratingLeveraging Strategic Relationships - Level 2, DemonstratingContinuous Learning – Level 2, DemonstratingAnalytical Thinking - Level 2, DemonstratingFoundational CompetenciesAccountability and OwnershipIntegrity and TrustValues Diversity and Inclusion
Education:Minimum Education/Degree Requirements*Veterinary degree(DVM or VMD) required from an accredited veterinary school withThree (3) Years of veterinary practice experience or Pharmacovigilance,Pharmacoepidemiology or related field experience.Previous pharmaceutical industry or drug safety/pharmacovigilance experiencepreferred.