Sr. Drug Safety Specialist

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.

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.