Remote Pharmacovigilance Specialist (Medical Safety)

Biomapas Group; United States; In loco; USD 85.000 - 125.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus based on annual performance

Personal accident and business trip保险

Remote/home based

Descrizione del lavoro

Biomapas Group is seeking a Pharmacovigilance Specialist (Medical/Clinical Safety) to join our global PV team. The role ensures compliance with the Quality Management System and oversees safety information collection, review, processing and reporting in line with global and local regulations.

Based anywhere in the EU with remote/home-based options, you will handle SAE/ICRS processing, safety data reconciliation, DSUR/PSUR/RM planning and cross-functional collaboration.

Competenze

• University degree in Life Science.
• At least 4+-years’ experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation.
• Knowledge of international regulations (ICH, EU GVP Modules, FDA).
• Experience working with PV databases (e.g., Argus, ArisG) and MedDRA coding.
• Ability to interpret and apply global drug safety regulations.
• Fluent English and local country language.
• Eager to adopt automations and new technologies in daily tasks.
• Attention to detail, time-management and problem-solving skills.
• Project management experience is beneficial.

Mansioni

• Process Safety Information: SAE/ICRS processing, safety database entry, narrative writing, follow-up requests, and safety reporting to clients/agencies.
• Perform reconciliation of safety data.
• Participate in Project/Study Team meetings as Safety and Pharmacovigilance representative.
• Oversee planning, coordination, and quality review of aggregate safety reports; support regulatory safety document submissions (DSURs, 6MLL).
• Supervise local handling, including preparation and submission of PSURs, Risk Management Plans and RM activities.
• Collaborate with medical, safety physicians, data management, IT, and other functions for timely reporting.
• Act as Biomapas and/or contractual partners 24/7 local PV contact or backup.
• Ensure monitoring of national/regional pharmacovigilance regulations.
• Collect and process medical enquiries via phone/email/fax.
• Support weekly literature monitoring and safety signal evaluation.
• Support inspections and audits as needed.

Conoscenze

Attention to detail

Time management

Problem solving

Project management (beneficial)

Formazione

University degree in Life Science

Strumenti

Argus

ArisG

MedDRA coding

Descrizione del lavoro

Biomapas Group is seeking a Pharmacovigilance Specialist (Medical/Clinical Safety) to join our global PV team. The role ensures compliance with the Quality Management System and oversees safety information collection, review, processing and reporting in line with global and local regulations.

Based anywhere in the EU with remote/home-based options, you will handle SAE/ICRS processing, safety data reconciliation, DSUR/PSUR/RM planning and cross-functional collaboration.