Pharmacovigilance Veterinarian

4 weeks ago

Duluth, United States US Tech Solutions Full time

Duration: 12 Months Contract (Extension Possible)


Note: 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 minimumof 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 PVWorks, 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.


Education:

Minimum Education/Degree Requirements* Veterinary degree(DVM or VMD)required from an accredited veterinary school with Three(3) Years of veterinary practice experience or Pharmacovigilance, Pharmacoepidemiology or related field experience.

Previous pharmaceutical industry or drug safety/pharmacovigilance experience preferred.



About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit


US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


Recruiter Details:

Name: Swati

Email: swati.tiwari@ustechsolutionsinc.com

Internal Id: 24-18659

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