About This Role

As a Clinical Trial Management PV Lead, you will play a pivotal role in ensuring the operational excellence and strategic oversight of safety processes, contents and data quality within clinical studies. Positioned within our pharmacovigilance team, this role is integral to maintaining compliance with global safety regulations while driving innovation in safety data review and management practices. From utilizing tools and processes for safety database configurations to leading quality reviews of Individual Case Safety Reports (ICSRs), you will be instrumental in shaping our clinical safety initiatives. Your expertise will support cross-functional collaborations, enhance safety data quality, and contribute to regulatory filings and ongoing safety surveillance and risk management activities. As a senior leader in the team, you will identify areas for improvement within the pharmacovigilance system, lead strategic initiatives, and contribute to the development and update of procedural documents. This position offers an exciting opportunity to work at the intersection of clinical development, pharmacovigilance, and regulatory compliance, making a meaningful impact on patient safety and clinical trial success.

 What You’ll Do

• Responsible for safety operational processes and strategic content pertaining to clinical studies such as protocols, ICFs, CRFs, safety management plans, study forms, CSRs, SAPs ; tools and processes for safety database requirements and configurations to enable safety-related activities during studies;
• Responsible for developing training requirements and materials for clinical trial safety data reporting and collection (e.g. Investigator meetings, Site Initiation Visit),
• Support clinical trial safety report collection and collaborate with other functions (e.g., Clinical Operations, Data Management, Regulatory, Biostatistics, and others) to ensure consistency with regulations and study objectives
• Lead the quality review of ICSRs and oversee the KPIs pertaining to data quality
• Lead data quality related root cause analysis, QE investigation and CAPA management
• Lead the safety data review and analysis of clinical studies and support ongoing safety surveillance activities, aggregate reports (DSUR, SUSAR LLRs), development of safety contents in CSRs and regulatory filings (e.g. BLA, MAA)
• Contribute to business alliance management pertaining to relevant clinical studies
• Review and archive PV related records in various documentation management systems (e.g. TMF)
• Identify gaps and areas of improvement within the PV system and lead strategic initiatives to address them
• Develop, maintain and implement PV related procedural documents (e.g. SOPs)

 Required Skills

• Bachelor’s degree in a biological or natural science, or health care discipline (e.g. nursing, pharmacy).
• Eight (8)+ years of pharmacovigilance and GCP experience required
• Extensive experience in case processing (data entry, QC, coding) and handling of ICSRs including submissions and exchanges in both clinical trial and post-marketing settings required
• Hands-on experience in clinical study documents (e.g. protocols, ICFs, CSRs)
• Proficient in Argus
• Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
• Strong analytic and organizational skills, including the ability to handle complex tasks, prioritize effectively, and project management initiatives/process improvements.
• Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
• Demonstrated ability to work proactively and independently with minimal oversight needed by management.

Preferred:

• Hands-on experience in supporting NDA/BLA/MAA filings and responses to Health Authorities Queries required
• Advanced Degree (M.D., Ph.D., MPH, NP, PharmD, etc.)
• Hands-on experience in aggregate safety reports (e.g. DSUR, PBRER, SUSAR LLRs) preferred

Additional Information