Regulatory Affairs Specialist / Pharmacovigilance Officer

ProPharma has improved patient health for 20 years by providing expertise that empowers biotech, med device, and pharmaceutical organizations to advance breakthroughs and introduce therapies. It partners through an advise-build-operate model across the product lifecycle. Deep domain expertise covers regulatory sciences, pharmacovigilance, quality, compliance, and more.

Handle regulatory affairs by preparing applications for marketing authorizations, variations, notifications, and renewals for medicinal and non-medicinal products. Prepare supporting documentation for market placement, maintenance, recalls, and pricing reimbursements. Review marketing materials against registered dossiers and local legislation.

Manage pharmacovigilance through regular monitoring of local and EU PV legislation and CA web pages. Collect, assess seriousness, database, and forward Individual Case Safety Reports (ICSRs) with expedited reporting to local CA and EudraVigilance. Screen literature, websites, and social media for safety information while tracking PSUR deadlines.

Participate in product teams to implement regulatory requirements in production and communicate with Competent Authorities. Develop and maintain knowledge on local and EU legislation, prepare training materials, and supervise less experienced RA employees. Participate in RA audits, inspections, and review SOPs and service agreements.