Patient Safety and Pharmacovigilance Specialist

This is a fully remote position, open to applicants in Romania, +1 more country.

📋 Description

• Implement international adverse event and pharmacovigilance procedures in line with regulatory agency standards.

• Oversee adverse event and pharmacovigilance operations for global sites.

• Deliver support, training, and guidance for drug safety initiatives, including product quality complaints and medical information services.

• Supervise the pharmacovigilance system with monthly performance assessments.

• Prepare and evaluate PV metrics, encompassing KPIs, quality incidents, CAPAs, audits, and inspection results.

• Gather and analyze compliance data; perform root cause analyses, gap assessments, and evaluations of corrective action effectiveness.

• Review safety reports and study documentation for thoroughness, precision, and clinical significance.

• Aid in audit and inspection preparedness and support internal audits and health authority inspections.

• Conduct training on adverse event reporting and engage in both internal and external meetings.

• Manage the safety mailbox, evaluate adverse event reports, and coordinate medical assessments and escalations.

• Collaborate with cross-functional teams to improve PV compliance.

• Draft Safety Monitoring Plans and process adverse events in the Argus database.

• Review and submit safety reports to regulatory bodies, address inquiries, and maintain adverse event records.

• Perform literature reviews for adverse event identification, reconcile AE reports with partners, and handle product complaints.

• Act as a pharmacovigilance subject matter expert, support business development, train and oversee personnel, and assist with resource onboarding.

⛳️ Requirements

• A Bachelor's degree in medical, nursing, pharmaceutical, or life sciences is mandatory.

• A minimum of 3 years of experience in drug safety or pharmacovigilance within the CRO or pharmaceutical sector.

• Familiarity with Clinical Trials and drug development phases 1 through 4.

• Strong verbal and written communication abilities.

• Proficient knowledge of the Argus Safety Database.

• Computer literacy with expertise in Microsoft Office, specifically Word, Excel, and PowerPoint.

• Understanding of FDA regulations and ICH guidelines.

• Excellent organizational skills and meticulous attention to detail.

• Capability to thrive in a fast-paced environment and adeptly manage shifting priorities.

🏝️ Benefits

• Wellness, growth, and development programs.

• Team-building and team event initiatives.

• A diverse and supportive work culture.

• Reasonable accommodations for qualified individuals with recognized disabilities.