Medical/Clinical Safety Specialist

Position Overview

Become a crucial member of our global Pharmacovigilance team by taking on the role of Medical/Clinical Safety Specialist. This specialist position ensures adherence to our Quality Management System by managing the collection, safety evaluation, processing, and reporting of safety data according to worldwide and local legal requirements, alongside Biomapas' standard protocols. The role requires active communication and exchange of pharmacovigilance data with local Competent Authorities, Biomapas, and its contractual partners.

This position is open to candidates located anywhere within the European Union. Applications must be submitted in English.

Key Responsibilities

• Handling Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) from clinical trials, including database entry, follow-up requests to sites, narrative development, quality assessments, and reporting to clients or regulatory bodies for assigned projects.
• Conducting safety data reconciliation to maintain data integrity.
• Representing safety and pharmacovigilance aspects in project and study team meetings.
• Leading the planning, coordination, and quality review of aggregate safety reports, and assisting with the preparation and submission of regulatory documents such as Development Safety Update Reports (DSURs) and six-month line listings (6MLL).
• Managing local tasks related to preparation and submission of Periodic Safety Update Reports, Risk Management Plans, and implementation of risk minimization strategies.
• Collaborating closely with medical personnel, safety physicians, data management, IT, and other departments to ensure timely and accurate delivery of safety reports.
• Serving as a 24/7 local contact point or backup for pharmacovigilance on behalf of Biomapas or its contractual partners.
• Keeping abreast of and monitoring national and regional pharmacovigilance regulations.
• Collecting and processing medical inquiries received through various communication channels.
• Supporting weekly reviews of local and global literature concerning pharmacovigilance.
• Assisting ongoing monitoring of safety profiles to identify emerging safety signals and perform evaluations.
• Participating in inspections or audits related to the pharmacovigilance function and providing necessary follow-up support.

Required Qualifications

• University degree in a Life Sciences discipline.
• Minimum of five years’ professional experience within pharmacovigilance, clinical safety, and clinical development, demonstrating expert understanding of pharmacovigilance legislation.
• In-depth knowledge of international regulations including ICH guidelines, EU Good Pharmacovigilance Practices (GVP) modules, and FDA regulations.
• Practical experience using pharmacovigilance databases such as Veeva Vault Safety, Argus, ArisG, and proficiency in MedDRA coding.
• High competence in computer usage and software navigation.
• Capability to interpret and apply global drug safety regulations effectively.
• Fluency in English (written and spoken) is mandatory.
• Enthusiasm for embracing automation and new technological tools to enhance daily workflows.
• Strong attention to detail, effective time management, and problem-solving abilities.
• Experience working with Contract Research Organizations (CROs) is advantageous.
• Project management experience is a plus.

Benefits and Perks

• Opportunities for professional growth and career advancement within an international work environment.
• Annual performance-based bonus system.
• Personal accident and business trip insurance coverage.
• Additional health insurance benefits.
• Work from home or remote arrangements supported.
• Attractive reward scheme for successful referrals.
• Financial support for establishing a home workplace (for fully remote workers).
• Participation in team-building events, global meetings, and wellness initiatives.