Senior Specialist, Global Pharmacovigilance (Animal Health)

Job Description

The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:

• Case review/approval for assigned products

• Expedited case submission according to timelines outlined in applicable regulations

• Case entry for non-PV-Works countries for assigned products

• Aggregate report preparation and submission to National Teams or Competent Authorities according to timelines outlined in applicable regulations

• Support national PV teams as applicable

• Product expert for assigned products

• Provide qualified answers to questions raised by internal or external stakeholders (e.g., Competent Authorities) for products for which the Senior Specialist is responsible

• PV Statement preparation in compliance with relevant regulations, policies, and procedures

• Same/similar designation of assigned products

• Allocation of new product activated in PV-Works to the applicable product family

• Risk management for assigned products

  • Participation in signal management activities, including (but not limited to) signal detection, prioritization, validation, assessment, and recommendation for action

  • Signal management statement preparation and, if applicable, submission to Competent Authorities according to timelines outlined in applicable regulations

  • Analysis of peer-reviewed literature

  • Review of clinical study data

  • Participation in risk communication planning

  • Participation in the design and/or fulfillment of supplementary monitoring activities

  • Development of risk minimization strategies

• Archive all relevant documents/communications as agreed or defined in the applicable procedures

Additional activities may include at least one of the following:

• Participation in team meetings

• Participation in audits/inspections as applicable

• Support CAPA completion activities as applicable

• Support GPV procedure management

• Support training

• Provide business support for pharmacovigilance database systems (e.g., review validation documents and execute User Acceptance Tests (UATs) for functionality changes)

• Perform literature searches

• Function as Content Lead for one or more GPV sub-teams (e.g., training, risk management, procedure management):

  • Establish team priorities and allocate resources accordingly

  • Provide oversight of team projects/activities, including tracking progress and compliance with projected timelines

  • Facilitate group meetings

  • Manage team questions and engage in problem solving to address concerns as they arise

  • Consult PVLT for guidance and feedback on team activities as needed

• Participation in projects as agreed with the manager

This position is based at our Rahway, NJ facility with a hybrid work schedule.

DESIRED QUALIFICATIONS:

• Knowledge of regulations governing pharmacovigilance for veterinary medicines

• Experience with PV databases

• Strong analytical, communication, and writing skills

• Experience with biostatistics and epidemiological principles

• Animal Health/Animal Science background is highly preferred

ACADEMIC REQUIREMENTS:       any of:

• DVM or PhD in a clinically/scientifically relevant field

• MS or equivalent in a clinically/scientifically relevant field with 3 years of experience in a highly regulated pharmaceutical field

• BA/BS or equivalent in a clinically/scientifically relevant field with 5 years of experience in a highly regulated pharmaceutical field

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive