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Your Role: Analyst - GDPS
The Analyst in PV Case Processing is responsible for managing adverse event reports, ensuring data accuracy, and maintaining compliance with global pharmacovigilance regulations and timelines. The role involves data entry, assessing seriousness and causality, and ensuring the completeness and quality of cases for regulatory submission. Effective communication skills, knowledge of regulations, and the ability to manage multiple priorities are essential. The Analyst must demonstrate Elanco core values, adaptability, and commitment to high-quality standards in all tasks.
Your Responsibilities:
Adverse Event Case Processing -
· Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database
· 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 events and product complaint case processing, and case submission processes as appropriate.
· Typical case processing activities include (but not limited to):
o Validation of data entry against source document(s) and call notes as appropriate.
o Assessment of adverse event reports for seriousness, reportability's and causality including reason for assessment.
o Perform self-review of all data for completeness, correctness and quality.
o Ensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authorities.
o Determine what, if any, follow-up information is needed
o Ensure to meet the expected productivity and quality standards.
o Active participation in team meetings.
o Perform other duties as assigned.
What You Need to Succeed (minimum qualifications):
Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience; or Bachelor’s degree in Life Sciences related field with 0-2 years of pharmacovigilance experience.
What will give you a competitive edge (preferred qualifications):
· Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting.
· Effective verbal and written communication skills to liaise with internal and external stakeholders.
· Ability to work effectively on multiple products and effectively manage priorities.
· Ability to establish and maintain effective working relationships with coworkers, managers and relevant stake holders.
· Capable of adhering to applicable, global, local regulatory requirements.
· Skill in using multiple databases.
· Ability to support during high volumes and flexibility to work extended hours when required.
· Self-motivated, flexible, and receptive to changes.
Additional Information:
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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
