Job Description Summary

Primarily responsible for all activities related to the Global Pharmacovigilance (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. Additionally, as a more advanced case processor, responsible for activities that support training, compliance, regulation changes, and the shaping of process improvements.

Job Description

Essential Responsibilities

• Receive, triage and process adverse events and medical device reports from all sources including post-marketing, clinical trials and published literature
• Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
• Perform data entry and quality review of adverse event reports into the global safety database, including accurate coding of MedDRA terms and preparation of case narratives
• Identify missing or discrepant information and perform active case follow-up via verbal or written contact
• Review expedited reports for submission to regulatory authorities and ethics committees
• Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., Regulatory Affairs, Medical Affairs, Quality Assurance, clinical development teams, CROs, etc.)
• Perform reconciliations between clinical, quality and PV databases
• Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
• Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
• Serve as pharmacovigilance resource and subject matter expert during inspections and audits
• Vendor oversight as needed, collaborating with external project leaders and teams to develop solutions, provide appropriate training, and monitor quality
• Provide oversight of clinical trials, requesting study configurations and developing study-specific job aids, as needed.
• Oversee workflow management and case prioritization to maintain compliance with regulatory timelines
• Provide Compliance group with root cause analysis and CAPA for late submissions
• Troubleshoot questions and issues with team, including database functionality, case processing conventions, and report submission failures; provide guidance based on experience and Data Handling Conventions
• Assist with writing and updating of SOPs and other guidance documents, in response to process improvements or changing regulations
• Participate in database projects and user acceptance testing, as needed, providing insight from business / case processing perspective

Qualifications/Requirements

• Extensive years in pharmaceutical/biotechnology industry with experience in Pharmacovigilance including clinical trials and post-marketing.
• Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review, expedited report review and scheduling, and follow-up with reporters.
• Strong understanding of Safety Database functionality and business workflow to be able to perform root cause analyses and troubleshoot
• Confidence in decision-making, taking into consideration data handling conventions, but also industry expectations and regulations
• Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
• Demonstrated ability to train and coach PV personnel
• Demonstrated ability to manage own workload, prioritize, plan and organize assignments and work within strict timelines
• Understanding of Microsoft Office applications, specifically Excel and Word

Desired Characteristics

• Healthcare professionals with clinical experience preferred.
• Experience with Argus preferred.
• Demonstrated initiative, teamwork, and accountability.
• Demonstrated ability to manage and independently drive projects to completion, in addition to overseeing day-to-day case processing needs.

Note:
To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years’ experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Additional Information