Job Description
Pay range: $41-54/hr
*based on experience
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
~Bachelors degree in life sciences, pharmacy, or related field.
~3+ years of pharmacovigilance operations experience, specifically working on planning and implementation related to geographic expansion of marketed products.
~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 related to 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 Tags
Remote job, Contract work, Work at office, Local area,