7 Quality Engineering jobs in Sofia.

Hiring now: Sr Pharmacovigilance Pv P @ Ergomed, Pv Officer @ Primevigil, Regulatory And Start Up S @ Iqvia, Local Qualified Person Fo @ Parexel.Explore more at jobswithgpt.com.

šŸ”„ Skills

Pharmacovigilance (3) QPPV (3) risk management (2) mentoring (2) Individual Case Safety Reports (2) training (2) ICSRs (1) signal detection (1) aggregate reports (1) medical review (1)

šŸ“ Locations

Sofia (7)

Ergomed

Skills & Focus: Pharmacovigilance, ICSRs, signal detection, aggregate reports, risk management, QPPV, medical review, safety assessment, mentoring, regulatory authority

Primevigilance

Skills & Focus: Case Processing, Pharmacovigilance, Individual Case Safety Reports, SAE/SUSAR Management, Periodic Reporting, Mentoring, Training, Workflow Cycle, Database Outputs, Regulatory Compliance
About the Company: PrimeVigilance is involved in case processing services related to pharmacovigilance, supporting various clinical trial and post-marketing activities.
Experience: Several years in case processing with a life science/bio medical background
Type: Full-time

Iqvia

Skills & Focus: Site Activation, regulatory documents, clinical research, SOPs, project timelines, quality control, local regulations, Clinical systems, project planning, communication skills
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: 3 years clinical research experience, including 1 year experience in a leadership capacity.
Type: Full time
Benefits: Benefits programs are designed to meet your total well-being needs so you can thrive at work and at home.

Primevigilance

Skills & Focus: case processing, pharmacovigilance, Individual Case Safety Reports, SAE management, submissions, periodic reporting, mentoring, training, procedure optimization, workflow management
Experience: Several years in case processing

Iqvia

Skills & Focus: TMF management, Quality review, stakeholders, KPI, records management, GCP-regulated, eTMF, data analytics, interpersonal skills, training
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Minimum 5 years pharmaceutical / biotechnology industry experience; Minimum 3 years records management experience in a GCP-regulated environment
Type: Full time
Benefits: Benefits programs are designed to meet your total well-being needs so you can thrive at work and at home.

Parexel

Skills & Focus: Pharmacovigilance, QPPV, freelance, clinical trials, post-market, safety reporting, risk management, GVP, GCP, regulations
About the Company: Parexel is in the business of improving the world’s health. They provide a suite of biopharmaceutical services that help clients across the globe transform sci…
Experience: Minimum of at least 7 years' demonstrated experience in managing or implementing PV systems, including quality assurance experience.
Type: Freelance

Ergomed

EU QPPV Sofia
Skills & Focus: QPPV, adverse reactions, medicinal product, safety studies, CAs, risk evaluation, marketing authorization, safety profiles, back-up procedures, safety concerns