Analyst- Pharmacovigilance at Elanco

Urgent
Posted 6 months ago
Bengaluru, Karnataka
Application deadline closed.

Job Description

Analyst- Pharmacovigilance

Elanco

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? search our job listings below.position description:the analysáš­ – 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:1. adverse event case managementresponsible for data entry, assessment, management, and submission of adverse event reports in the pv databaseresponsible for the completeness and accuracy of data collection and entry, case assessment, and… other associated case management activitiesidentifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriatedevelop an understanding of pharmacovigilance regulationscomply with internal and external timelines for managing adverse event and product complaint data entry, case processing, and case submission processes as appropriatetypical case management processing activities include (but not limited to):validate/perform data entry against source document(s) as appropriatecreation of a case narrativeidentify concomitant medications and relevant medical historyadditional case management activities may include (but not limited to):completion of case management activities related to business partnerships as necessaryattempt to obtain follow-up information from external parties through effective written and oral communicationsperform typical case management assessment activities which include (but not limited to):perform review of all data for completeness, correctness and qualityensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authoritiesdetermination of whether gpv review is necessarydetermine what, if any, follow-up information is needed2. global gpv supportkeep current on global regulatory issues and practices related to gpvassist with support of internal partners in gpv related activities as necessarypartner and communicate with gpv colleaguesmanagement of global adverse events mailboxperform regulatory submissions of individual case reportsparticipate in workgroup meetings and follow-up activities for assigned project, if required3. collaboration/support internal and external customerscommunicate effectively with elanco contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groupsunderstand the confidential nature of company information and take necessary steps to ensure its protectionensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside partiesminimum qualification (education, experience and/or training, required certifications):veterinarian (bvsc/mvsc/equivalent to us dvm degree)0-2 years experience in veterinary pharmacovigilance.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