Remote Pharmacovigilance Specialist – Clinical Safety

Employers from Greece; United States; À distance; USD 73 000 - 107 000; Plein temps

Avantages offerts par ce poste

Remote work (fully)

Health insurance

Professional growth

International team

Annual performance bonus

Personal accident insurance

Travel insurance

Workplace establishment allowance (ful

Résumé du poste

Biomapas in the EU seeks a Pharmacovigilance Specialist (Medical/Clinical Safety) to ensure compliance with the QMS and oversee safety data collection, review and reporting for global projects.

The role requires a life sciences degree, 4+ years PV experience, regulatory knowledge (ICH/EU GVP/FDA), experience with Argus/ArisG, and fluent English with a local language. Fully remote across EU.

Qualifications

• University degree in the Life Science field.
• 4+ years of pharmacovigilance, clinical safety and development experience.
• Knowledge of ICH, EU GVP Modules and FDA regulations.
• Experience with safety databases (Argus, ArisG) and MedDRA coding.
• Ability to interpret and apply global drug safety regulations.
• Fluent English and local country language.
• Willingness to adopt automation and new technologies.
• Strong attention to detail, time management and problem solving.
• Project management experience is a plus.

Responsabilités

• Process ICSSRS and SAEs from clinical trials, enter data, track, write narratives, request follow-up, and report to clients or agencies.
• Perform reconciliation of safety data.
• Participate in study team meetings as Safety and Pharmacovigilance representative.
• Oversee planning, coordination and QA of aggregate safety reports; support DSURs and 6MLL.
• Supervise local handling and submission of PSURs and risk management plans.
• Collaborate with medical, safety physicians, data management, IT and other functions to ensure timely reporting.
• Act as Biomapas and/or contractual partners 24/7 local PV contact or backup.
• Ensure monitoring of national/regional PV regulations.
• Collect and process medical inquiries via phone/email.
• Support weekly local/global literature monitoring.
• Support continuous safety profile monitoring and signal evaluation.
• Participate in inspections and audits as needed.

Connaissances

Pharmacovigilance

Clinical safety

Regulatory knowledge

MedDRA coding

Data interpretation

English proficiency

Local language

Automation awareness

Project management

Formation

University degree in Life Sciences

Outils

Argus

ArisG

Description du poste

Biomapas in the EU seeks a Pharmacovigilance Specialist (Medical/Clinical Safety) to ensure compliance with the QMS and oversee safety data collection, review and reporting for global projects.

The role requires a life sciences degree, 4+ years PV experience, regulatory knowledge (ICH/EU GVP/FDA), experience with Argus/ArisG, and fluent English with a local language. Fully remote across EU.