Senior Drug Safety Specialist

******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****** ================================== **Relocation Assistance Provided:** No