Elanco Hiring Associate Manager – Pharmacovigilance

Elanco Hiring Associate Manager – Pharmacovigilance

11 July, 2022

Elanco Hiring Associate Manager – Pharmacovigilance

Position Description:

The Associate Manager – PV Case Processing, is responsible for adverse event and product complaint report handling. This includes assessing and processing individual adverse event and product complaint reports; maintaining awareness of global pharmacovigilance regulations; ensuring regulatory compliance for expedited submission of individual case reports; collaborating with internal and external business partners; as well as other duties as assigned. A case processor’s responsibilities can vary depending on the needs and focus of a particular team.

Functions, Duties, Tasks:

  • Adverse Event Case Processing and Management
  • Responsible for assessment, management, and submission of adverse event reports in the PV database
  • Responsible for the completeness and accuracy of data collection and entry, case assessment, and other associated case management activities
  • Identifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriate
  • Develop an understanding of pharmacovigilance regulations
  • Comply with internal and external timelines for managing adverse event and product complaint case processing, and case submission processes as appropriate
  • Typical case processing activities include (but not limited to):
  • Validation of data entry against source document(s) as appropriate
  • Assessment of adverse event reports for seriousness, reportabilities and causality including reason for assessment.
  • Additional case management activities may include (but not limited to):
  • Completion of case management activities related to business partnerships as necessary
  • Attempt to obtain follow-up information from external parties through effective written and oral communications
  • Perform typical case management assessment activities which include (but not limited to):
  • Perform review of all data for completeness, correctness and quality
  • Ensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authorities
  • Determination of whether GPV review is necessary
  • Determine what, if any, follow-up information is needed
  • Global GPV Support
  • Keep current on global regulatory issues and practices related to GPV
  • Assist with support of internal partners in GPV related activities as necessary
  • Partner and communicate with GPV colleagues
  • Management of global adverse events mailbox
  • Perform regulatory submissions of individual case reports
  • Participate in workgroup meetings and follow-up activities for assigned project, if required
  • Collaboration/Support Internal and External Customers
  • Communicate effectively with Elanco contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groups
  • Understand the confidential nature of company information and take necessary steps to ensure its protection
  • Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties

Minimum Qualification (education, experience and/or training, required certifications):

  • Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience; or Bachelor’s degree in Life Sciences related field with minimum of 2 years of pharmacovigilance experience.

Additional Preferences:

  • Animal health care experience or animal health pharmacovigilance experience preferred
  • Highly-organized and detailed oriented
  • Strong verbal and communication skills

Apply HERE

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