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