ERGOMED

Associate Senior Pharmacovigilance Manager, PV systems

ERGOMED

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇷🇸 Serbia

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Job Level

Senior

Tech Stack

Cloud

About the role

  • Lead the development and delivery of complex standard and custom reports to meet evolving regulatory requirements and strategic internal needs
  • Oversee database design, set-up, and configuration, ensuring alignment with protocol and product-specific requirements in collaboration with IT, Safety, and Project Management teams
  • Lead validation efforts for computerized PV systems, maintaining compliance with GxP, 21 CFR Part 11, and other regulatory frameworks
  • Strategically manage data migration activities between legacy and modern safety databases, ensuring integrity, traceability, and completeness throughout
  • Develop and deliver advanced training programs on safety database processes, ensuring smooth onboarding and upskilling across regions
  • Act as a Subject Matter Expert (SME) for safety system configurations supporting global pharmacovigilance processes
  • Oversee Cumulative Data Quality Reviews (CDQRs), and drive proactive data integrity initiatives across safety platforms
  • Drive the creation, implementation, and refinement of SOPs, guidelines, and work instructions pertaining to safety database operations
  • Champion continuous improvement initiatives to optimize database performance, user experience, and compliance posture
  • Collaborate with global cross-functional teams (IT, QA, Regulatory, PV Operations, and Commercial) on system enhancements, issue resolution, and client delivery excellence
  • Provide strategic input and support to the Business Development and Commercial teams for proposals, RFPs, and client engagements, representing safety systems capabilities
  • Mentor and coach junior PV team members, building internal capabilities around safety systems and process excellence
  • Represent the PV Systems function in audits and inspections, and ensure readiness of database-related documentation and processes

Requirements

  • Life Science or Project Management, Business Analysis or IT Development Related Degree
  • Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech or CRO (on premise or cloud-based solution)
  • Organizational skills, including attention to detail and multitasking
  • Management skills, including time and issue management
  • Communication skills
  • Presentation skills
  • Ability to motivate/coach people
  • Leadership skills
Benefits
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
database designdata migrationdata integrityvalidation of computerized PV systemsSOP developmentreport developmenttraining program developmentsafety database operationspharmacovigilance systemsGxP compliance
Soft skills
organizational skillscommunication skillspresentation skillsleadership skillsmanagement skillsattention to detailmultitaskingcoachingmentoringcollaboration
Certifications
Life Science degreeProject Management degreeBusiness Analysis degreeIT Development degree