Job title: Associate Manager – PV Case Processing

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 provid

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, is responsible for adverse event and product complaint report handling for the Pharmacovigilance Case Processing team. This includes assessing and management of 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 Management Responsible for data entry, 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 data entry, case processing, and case submission processes as appropriate Typical case management processing activities include (but not limited to): Validate/perform data entry against source document(s) as appropriate Creation of a case narrative Identify concomitant medications and relevant medical history Additional case management activities may include (but not limited to): Completion of case management activities related to business partnerships as necessary Perform a review for accuracy, completeness, consistency, and adherence to GPV procedures 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 initial review of data for completeness and technical accuracy Code events to appropriate VeDDRA terms Manage and assess appropriate serious outcome criteria for adverse events Assess expectedness – evaluate the case against the appropriate product information 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 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): Associate’s degree (or equivalent) in veterinary medicine, OR Bachelor’s degree in Life Sciences related field with a minimum of 2 years experience Additional Preferences: Veterinary clinical experience or animal health pharmacovigilance experience preferred 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, 27 Apr 2022 22:52:24 GMT

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