Pharmacovigilance Compliance Specialist

Senior Pharmacovigilance Consultant with 10+ years’ success building and operating global PV systems across US/EU biotech and pharma, ensuring FDA/EMA compliance and strong cross-functional execution in remote settings

Leads inspection readiness through PV audits, gap analyses, SOP/WI authoring, and Safety Management Plans, aligning processes with 21 CFR, GCP, GVP, GDPR and ICH standards for robust regulatory integrity

Proven PV systems expert driving vendor selection and transitions (RFP to implementation), safety data and ICSR migrations, reconciliations, and KPI governance, with deep hands-on expertise in Argus and Veeva Vault

Delivers end-to-end PV operations including ICSR processing/submission oversight, literature monitoring and signal detection, DSUR/PSUR support, and early access program setup, ensuring operational excellence and patient safety

Developed a system for monitoring quality and compliance of services across multiple PV vendors

Created Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs)

Supported transition to a new PV vendor, including risk analysis, migration planning, and contingency-plan development

Assisted with ICSR and safety-database migration

Supported signal detection activities

Authored PV Standard Operating Procedures (SOPs) and related guidance documents

Led PV vendor selection, handling RFPs, bid defence, contract negotiation, and service implementation

Performed PV system audits and gap analyses

Developed Standard Operating Procedures (SOPs) to ensure compliance with 21 CFR, GCP, GVP, GDPR, and ICH guidelines

Directed Medical Information (MI) vendor selection and implementation

Established communication pathways and a responsibility matrix for MI processes

Authored SOPs for adverse events, product quality complaints, and MI handling, as well as SOP for Field Alert Report management

Managed transition to a new PV vendor, setting up processes and migrating safety data and ICSR records

Created Safety Management Plans (SMP) and associated forms (Serious Adverse Event, Pregnancy report)

Developed SOPs complying with 21 CFR, GCP, GVP, GDPR and ICH

Co-ordinated closely with Quality Assurance, Clinical Operations, Data Management, Regulatory Affairs, Legal and Finance to ensure seamless operational support

Directed ICSR processing and submission, and supported development of the electronic case report form (eCRF)

Oversaw reconciliation between clinical and safety databases

Acted as PV Subject Matter Expert, contributing to clinical trial protocols, Investigator’s Brochure and other trial documents

Provided oversight of the designated PV vendor through scheduled meetings and KPI tracking

Successfully passed multiple internal PV system audits

Conducted literature monitoring and signal detection activities

Coordinated authoring and submission of Development Safety Update Reports (DSURs)

Oversaw the designated PV vendor through regular meetings and KPI measurement

Led transition to a new PV vendor, establishing processes and migrating safety data and ICSR records

Directed ICSR processing and submission

Performed literature monitoring and signal detection

Developed Safety Management Plans and related forms (Serious AE, Pregnancy report)

Authored SOPs ensuring compliance with 21 CFR, GCP, GVP, GDPR and ICH

Managed the company’s worldwide early-access program (expanded access, compassionate use), designing processes and required forms

Collaborated with cross-functional teams to revise SOPs and maintain regulatory alignment

Co-ordinated authoring and submission of DSURs and supported Periodic Safety Update Report (PSUR) development

Successfully passed multiple internal and external audits of the PV system

Managed multiple global license partners, handling negotiations, drafting, implementation and maintenance of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs)

Oversaw setup and maintenance of the safety database

Managed safety-data and ICSR migrations

Led multiple PV projects as primary contact, ensuring regulatory compliance, client satisfaction and cost-effectiveness

Supported bid defence and initial project setup

Mentored junior project managers

Assisted with audit preparation and regulatory inspections

Managed the company’s pharmacovigilance system as Deputy EU Qualified Person for Pharmacovigilance (QPPV), ensuring continuous compliance with European PV regulations

Led various PV projects to ensure regulatory compliance, client satisfaction, and cost-effectiveness

Directed project teams, fostering collaboration and efficient workflow

Maintained project-specific documentation and prepared monthly reports for invoicing

Provided support during audits and inspections

Delivered company-wide training on Argus Safety database

Managed ICSR processing using Oracle Argus Safety database and maintained associated documentation

Led a team of case processors, providing line-management and onboarding training

Developed and delivered team training sessions

Collaborated with cross-functional teams across the organization