Analyst - PV (Elanco)

Roles and Responsibilities

Your Responsibilities: -

1. 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):

• Validation of data entry against source document(s) and call notes as appropriate.

• Assessment of adverse event reports for seriousness, reportabilities and causality including reason for assessment.

• Perform self-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.

• Determine what, if any, follow-up information is needed

• Ensure to meet the expected productivity and quality standards.

• Active participation in team meetings.

• Perform other duties as assigned.

Skills & Abilities

• Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting.

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

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

What You Need to Succeed (minimum qualifications):

• 0-2 years of experience in PV

• Basic understanding of PV Case processing, Study Literature

• High Learning Agility

• Good Communication Skills

What will give you a competitive edge (preferred qualifications):

• Experience working on Pharmacovigilance (PV) case processing

Additional Information:

• Travel: 0%

• Location: India, Bangalore