Clinovo
Global Drug Safety Senior Case Specialist
Clinovo, Palo Alto, California, United States, 94306
Description: The Senior Case Specialist will support pharmacovigilance activities related to the geographic expansion of marketed products, with a particular emphasis on regulatory intelligence, safety database configuration, and QMS alignment. This role will serve as a key liaison between the PV Operations team, Safety Systems Management, and the EU QPPV office to ensure country-specific requirements are understood and implemented within PV systems and processes.
Essential responsibilities include: ~Monitor and interpret regulatory intelligence for new markets to identify pharmacovigilance obligations (e.g., ICSR reporting requirements, data retention, local authority expectations). ~Translate regulatory requirements into actionable configuration needs for the safety database and collaborate with Safety Systems Management to implement these changes. ~Support the development and maintenance of country-specific configurations, such as reporting rules, distribution pathways, and reference data. ~Liaise with the EU/UK QPPV offices to ensure that country expansion activities align with global PV system and QPPV requirements (e.g., PSMF, local literature monitoring, local contact points). ~Assist with the development, revision, and review of standard operating procedures (SOPs), work instructions, and quality system documentation related to global expansion activities. ~Collaborate cross-functionally to ensure teams are informed of safety database setup timelines, configurations, and regional implementation plans. ~Contribute to inspection readiness by ensuring accurate documentation of configuration decisions and alignment with global QMS standards. ~Support reconciliation and verification activities related to case intake, affiliate partner setup, and regulatory reporting pathways. ~Participate in system user acceptance testing (UAT) and impact assessments for configuration updates as needed.
Required Knowledge, Skills, and Abilities ~Bachelor's degree in life sciences, pharmacy, or related field. ~3+ years of pharmacovigilance operations experience, with exposure to global expansion or systems integration. ~Familiarity with regulatory intelligence and safety reporting requirements across multiple regions (e.g., EU, MENA, LATAM, APAC). ~Experience working with safety databases (e.g., Argus, ArisG, Vault Safety) and understanding of configuration and reporting logic. ~Knowledge of quality management systems (QMS), inspection readiness principles, and controlled document management. ~Strong collaboration skills and the ability to work across functions, including Information Systems (IS), Safety Systems Management (SSM), PV Operations Regulatory, and QPPV functions. ~Excellent documentation, analytical, and communication skills.
Required Qualifications ~Hands-on experience with Veeva Vault (Quality Docs, Vault Safety, or other modules). ~Previous experience supporting PV system configuration projects or geographic expansion activities. ~Experience working with EU QPPVs or PSMF support teams. ~Familiarity with global PV standards and frameworks (e.g., GVP, ICH E2E, E2B(R3)). ~Strong communication and cross-functional collaboration skills. ~Demonstrated ability to enhance pharmacovigilance processes by leveraging internal and external insights, staying current with regulatory developments, and applying industry best practices to drive continuous improvement. Job Posting Start Date: 08/12/2025 Job Posting End Date: 08/11/2026 Business Unit: R&D Site: US - Home-Based - PA Location: US - Home-Based - PA
Essential responsibilities include: ~Monitor and interpret regulatory intelligence for new markets to identify pharmacovigilance obligations (e.g., ICSR reporting requirements, data retention, local authority expectations). ~Translate regulatory requirements into actionable configuration needs for the safety database and collaborate with Safety Systems Management to implement these changes. ~Support the development and maintenance of country-specific configurations, such as reporting rules, distribution pathways, and reference data. ~Liaise with the EU/UK QPPV offices to ensure that country expansion activities align with global PV system and QPPV requirements (e.g., PSMF, local literature monitoring, local contact points). ~Assist with the development, revision, and review of standard operating procedures (SOPs), work instructions, and quality system documentation related to global expansion activities. ~Collaborate cross-functionally to ensure teams are informed of safety database setup timelines, configurations, and regional implementation plans. ~Contribute to inspection readiness by ensuring accurate documentation of configuration decisions and alignment with global QMS standards. ~Support reconciliation and verification activities related to case intake, affiliate partner setup, and regulatory reporting pathways. ~Participate in system user acceptance testing (UAT) and impact assessments for configuration updates as needed.
Required Knowledge, Skills, and Abilities ~Bachelor's degree in life sciences, pharmacy, or related field. ~3+ years of pharmacovigilance operations experience, with exposure to global expansion or systems integration. ~Familiarity with regulatory intelligence and safety reporting requirements across multiple regions (e.g., EU, MENA, LATAM, APAC). ~Experience working with safety databases (e.g., Argus, ArisG, Vault Safety) and understanding of configuration and reporting logic. ~Knowledge of quality management systems (QMS), inspection readiness principles, and controlled document management. ~Strong collaboration skills and the ability to work across functions, including Information Systems (IS), Safety Systems Management (SSM), PV Operations Regulatory, and QPPV functions. ~Excellent documentation, analytical, and communication skills.
Required Qualifications ~Hands-on experience with Veeva Vault (Quality Docs, Vault Safety, or other modules). ~Previous experience supporting PV system configuration projects or geographic expansion activities. ~Experience working with EU QPPVs or PSMF support teams. ~Familiarity with global PV standards and frameworks (e.g., GVP, ICH E2E, E2B(R3)). ~Strong communication and cross-functional collaboration skills. ~Demonstrated ability to enhance pharmacovigilance processes by leveraging internal and external insights, staying current with regulatory developments, and applying industry best practices to drive continuous improvement. Job Posting Start Date: 08/12/2025 Job Posting End Date: 08/11/2026 Business Unit: R&D Site: US - Home-Based - PA Location: US - Home-Based - PA