Medical/Clinical Safety Specialist

Summary

Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist responsible for assuring compliance with the Quality Management System. The role involves collecting, reviewing, processing, and reporting safety information according to global and local regulations and Biomapas' standard operating procedures. You will interact with local Competent Authorities, Biomapas, and partners, exchanging relevant safety and pharmacovigilance information. The position is based in any EU country. Responsibilities include processing ICSRs and SAEs, performing data reconciliation, participating in project team meetings, overseeing aggregate safety reports, and collaborating with various teams to ensure timely and accurate reporting. You will also act as a 24/7 local contact for pharmacovigilance and ensure monitoring of national/regional regulations.

Requirements

• University degree in the Life Science field
• At least 5+-year’s 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, ArisGlobal) and MedDRA coding
• Strong computer literacy
• Ability to interpret and apply global drug safety regulations
• Fluent English language
• Eager to adopt automations and new technologies in daily tasks
• Attention to detail, time-management and problem-solving skills

Responsibilities

• Responsible for processing of ICSRs, Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, narrative writing, requesting follow-up from site, quality checks/review and reporting to client (s) or agencies for assigned projects)
• Perform reconciliation of safety data
• Participate in Project / Study Team meetings as the Safety and Pharmacovigilance representative
• Oversee the planning, coordination, and quality review of aggregate safety reports, support the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL)
• Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities
• Collaborate with medical, safety physicians, and data management, IT, other functions to ensure timely and accurate reporting or reports delivery
• Act as Biomapas and/or contractual partners 24/7 local contact person or back up for pharmacovigilance at local level
• Ensure the survey and monitoring of national / regional pharmacovigilance regulations
• Collection and processing of any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source
• Support of weekly monitoring of local or global literature review
• Support of continuous safety profile monitoring, detection of new signals and evaluation
• Participate in related inspection and/or audits, including post inspection/audit support, when required

Preferred Qualifications

• CRO experience is a plus
• Project management experience is a plus

Benefits

• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home based
• Influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events