[Hiring] Medical/Clinical Safety Specialist @Biomapas

Role Description

Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist. The Medical/Clinical Safety Specialist is responsible for assuring compliance with the Quality Management System. This role involves:

• Participating in the collection, safety review, processing, and reporting of safety information in compliance with applicable global and local regulations and Biomapas standard operating procedures and guidelines.
• Interacting and exchanging relevant safety and pharmacovigilance information with local Competent Authorities, Biomapas, and Biomapas contractual partners.
• Position is in any EU country. All CV's must be submitted in English language.

Responsibilities include:

• 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 clients or agencies for assigned projects).
• Performing reconciliation of safety data.
• Participating in Project / Study Team meetings as the Safety and Pharmacovigilance representative.
• Overseeing the planning, coordination, and quality review of aggregate safety reports, supporting the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL).
• Supervising local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans, and risk minimization activities.
• Collaborating with medical, safety physicians, and data management, IT, and other functions to ensure timely and accurate reporting or reports delivery.
• Acting as Biomapas and/or contractual partners 24/7 local contact person or backup for pharmacovigilance at the local level.
• Ensuring the survey and monitoring of national/regional pharmacovigilance regulations.
• Collecting and processing any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source.
• Supporting weekly monitoring of local or global literature review.
• Supporting continuous safety profile monitoring, detection of new signals, and evaluation.
• Participating in related inspections and/or audits, including post-inspection/audit support, when required.

Qualifications

• University degree in the Life Science field.
• At least 5+-year’s experience in Pharmacovigilance, clinical safety, and clinical development with expert knowledge of pharmacovigilance legislation.
• Knowledge of international regulations (ICH, EU GVP Modules, FDA).
• Experience working with PV databases (e.g., Veeva Vault Safety, Argus, ArisG, etc.) 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.
• 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.
• Rewarding referral policy.
• Workplace establishment allowance (fully remote).
• Team building, global meetings, B active events.