Pharmacovigilance Specialist

4/2013 – 6/2015

Set up and oversee drug safety-related processes in clinical studies throughout their conduct.
• Contribute to study protocols with regard to operational pharmacovigilance aspects
• Set up safety collection and reporting processes based on the study protocol and regulatory requirements
• Provide support and guidance during the conduct of the study for drug safety-related issues
• Set up processes to ensure global and local regulatory reporting obligations are fulfilled
• Lead safety-related process discussions with central CROs for individual studies
• Conduct internal and external trainings including international roll-out of SAE reporting processes in studies
• Interface with Clinical Research, Medical Affairs, Quality Assurance, Clinical Operations, Data Management, Regulatory Affairs, CROs, Global Pharmacovigilance and local PV departments worldwide
• Participate in global projects and working groups, including:
◦ Represent GPV in working group with Data Management for developing interfacing processes, including the creation and global roll-out of the new SAE reconciliation process for all studies
◦ Lead global subgroup for process developing and harmonization for Investigator-Initiated Studies
◦ Represent GPV in the global decision body Clinical Standards Committee
◦ Update of global standard SAE reporting form and instructions
◦ Contribute to global Standard Operating Procedures

Biologie

6/2012 – 3/2013

Manage, process and review cases from any source from local PV Units, license partners and clinical studies
• Global case management: triage, data entry, coding (MedDRA and WHO-DRL), scientific review, querying
• Identify case-relevant information in medical reports
• Support local PV Units and vendors with case processing-related issues
• Perform training of junior associates
• Participate in global working groups within Case Management
◦ Training and Compliance: define training materials and ensure compliance within the team
◦ Global Case Management service mailbox system: architecture and process development

Biologie

10/2009 – 5/2012

Coordinate two teams of Drug Safety Associates performing case processing for international projects, ensuring quality of delivery to the client. Contact for Drug Safety at client level and for global study teams.
• Coordinate SAE/ADR case management from international studies (Phase I to III) and post-marketing surveillance, with line management responsibility for teams of Drug Safety Associates
• Implement client requests, including process set-up, monitoring and development
• Represent Pharmacovigilance within global project teams including representatives from Clinical Operations, Data Management, Medical Monitoring and Project Management
• Forecast project resourcing, including personnel needs and projected hours
• Develop drug safety project management plans
• Train and mentor junior Drug Safety Associates

Biologie

11/2006 – 9/2009

Manage drug safety information from clinical studies and marketed drugs from local sources
• Process Individual Case Safety Reports from clinical studies and post-marketing sources: collection, data entry, querying, reporting to Competent Authorities
• Create Periodic Safety Update Reports and report to the Authorities
• Answer drug safety-related queries from internal and external sources
• Participate in ad-hoc projects, including DHCP letters, risk management, labelling review, signal detection
• Perform Pharmacovigilance training to company staff, implementation of an on-line training platform
• Implement personal data protection laws in local pharmacovigilance activities
• Design of user requirements for local safety database and user acceptance tests
• Coordinate the processing of safety information received via legal claims
• Create local Standard Operating Procedures
• Train junior drug safety associates

Biologie