Assoc Mgr – Elanco Pv

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Job title: Assoc Mgr – Elanco Pv

Company: Elanco

Job description: As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

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:

1. 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

2. 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

3. 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

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 13 Jul 2022 22:48:02 GMT

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