Associate Manager - PV Case Processing
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Skills you'll use
What you'll do
- The Associate Manager – PV Case Processing is responsible for performing the assessment, management, and submission of adverse event reports in compliance with global pharmacovigilance regulations and timelines. This role involves data accuracy, completeness, and quality, manages regulatory submissions, and supports internal and external stakeholders through effective communication and collaboration.
- Your Responsibilities: -
- Identify issues in case processing that may result in a delay in submission and escalate issues to management as appropriate.
- Comply with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes as appropriate.
- Validation of data entry against source documents and call notes as appropriate.
- Attempt to obtain follow-up information from external parties through effective written and oral communications.
- Stay current on global regulatory issues and practices related to GPV.
- Understand the confidential nature of company information and take necessary steps to ensure its protection.
- What You Need to Succeed (minimum qualifications):
- Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience; or bachelor’s degree in pharmacy or Life Sciences related field with 4-7 years of pharmacovigilance experience.
Who can apply
- Strong understanding of medical terms, clinical concepts, and their relevance in adverse event case processing.
- Expertise in data entry, validation, and review processes to ensure completeness, accuracy, and quality of adverse event reports.
- Ability to establish and maintain effective communication and working relationships with coworkers, managers, and relevant stake holders.
- Willingness and aptitude to learn new skills in the field of safety.
- Team player with the ability to contribute and work towards achieving team goals.
- Ability to support during high volumes and flexibility to work extended hours when required.
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