18 days old

Associate Manager - PV

Elanco
Bengaluru, KA 560002
  • Job Code
    R0009340

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Functions, Duties, Tasks:

1. Adverse Event and Product Complaint Data Entry

  • Responsible for data entry of adverse event/product complaint reports in the PV database (on ad-hoc basis assessment will also be handled)
  • Responsible for the completeness and accuracy of data collection, data entry and case assessment activities.
    • Validate/perform data entry against source document(s) as appropriate
    • Review case narrative for completeness and accuracy
    • Identify and accurately document concomitant medications and relevant medical history
    • Determine what, if any, follow-up information is needed and attempt to obtain follow-up information along with clarifications of received data (if needed) from customer-facing team through effective written and oral communications
  • Perform typical case assessment activities which may include (but are not limited to):
    • Perform initial review of data for completeness and technical accuracy
    • Code events to appropriate VeDDRA terms
    • Assess appropriate serious outcome criteria for adverse events
    • Assess the reportability, causality and enter the reason for assessment in the case.
  • Additional case processing activities may include (but not limited to):
    • Completion of data entry and assessment activities related to business partnerships as necessary including MAH notifications within stipulated timelines
    • Perform a review for accuracy, completeness, consistency, and adherence to GPV procedures
  • Develop an understanding of veterinary pharmacovigilance regulations.
  • Demonstrate satisfactory knowledge of the regulatory, quality, and compliance requirements associated with execution of the role
  • Comply with internal and external timelines for managing adverse event and product complaint data entry and case assessments
  • Identify issues in case processing that may result in a delay in submission and escalate issues to management as appropriate
  • Other support activities including (but not limited to)

Allocation of the daily cases, identification of expedited cases and prioritization of such cases across the workflow Mentoring of the new team members for data entry activities

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 as required
  • Management of global adverse events mailbox
  • Support on PMRA incident forms for Canada

3. Collaboration/Support Internal and External Customers

  • Communicate effectively with Elanco business partners as needed
  • Assist with processing of reimbursement and product complaint requests
  • Perform review of contacts classified as inquiries to ensure lack of embedded adverse event or product complaint reports
  • 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
  • Identify opportunities for increased efficiencies and collaborate with business partners to implement solutions

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







Posted: 2022-01-07 Expires: 2022-02-05
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Associate Manager - PV

Elanco
Bengaluru, KA 560002

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