Job title: Associate Manager – Pharmacovigilance
Job description: 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. The Associate Manager – PV Case Processing, is responsible for adverse eve
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. 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. The 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 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 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 Participate in workgroup meetings and follow-up activities for assigned project, if required 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): Veterinarian (BVSc/MVSc/equivalent to US DVM degree) Minimum 2 years experience in veterinary pharmacovigilance . Additional Preferences: Highly-organized and detailed oriented Strong verbal and communication skills 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
Location: Bangalore, Karnataka
Job date: Wed, 23 Feb 2022 23:04:21 GMT
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