Medical/Clinical Safety Specialist

About the Role

Join our international Pharmacovigilance team as a Medical/Clinical Safety Specialist responsible for ensuring compliance with our Quality Management System. This role involves managing the collection, review, processing, and reporting of safety information in strict accordance with global and local regulations as well as our internal standard operating procedures. Effective communication with local Competent Authorities, Biomapas, and our contractual partners is essential.

Key Responsibilities

• Manage Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) from clinical trials including database entry, tracking, narrative writing, follow-up requests, quality reviews, and reporting to clients or regulatory agencies.
• Conduct reconciliation of safety data to ensure accuracy.
• Serve as the Safety and Pharmacovigilance representative during Project/Study Team meetings.
• Oversee planning, coordination, and quality review of aggregate safety reports and assist in the preparation and submission of regulatory safety documents such as Development Safety Update Reports (DSURs) and 6-Month Line Listings (6MLL).
• Manage local processes for Periodic Safety Update Reports, Risk Management Plans, and risk minimization activities, ensuring timely preparation and submission.
• Collaborate with medical professionals, safety physicians, data management, IT, and other departments to guarantee timely and accurate delivery of reports.
• Act as the 24/7 local contact or backup for pharmacovigilance matters for Biomapas and its contractual partners.
• Maintain up-to-date knowledge and monitoring of national and regional pharmacovigilance regulations.
• Handle and process medical enquiries received via various communication channels.
• Support weekly reviews of local and global literature related to safety.
• Assist in continual safety profile monitoring, signal detection, and evaluation.
• Participate in inspections and audits and provide post-inspection/audit support as required.

Required Qualifications and Experience

• A university degree in a Life Sciences field.
• A minimum of five years’ experience in Pharmacovigilance, clinical safety, and clinical development with deep knowledge of pharmacovigilance legislation.
• Familiarity with international regulatory frameworks such as ICH guidelines, EU Good Pharmacovigilance Practices (GVP) Modules, and FDA regulations.
• Experience working with pharmacovigilance databases including Veeva Vault Safety, Argus, ArisG, as well as proficiency in MedDRA coding.
• High level of computer literacy and ability to adapt to automation and new technological tools.
• Strong analytical skills allowing for interpretation and application of global drug safety regulations.
• Fluency in English is mandatory.
• Excellent attention to detail, time management, and problem-solving abilities.
• Experience in a Contract Research Organization (CRO) and project management is advantageous.

Benefits and Perks

• Opportunities for professional development and career progression.
• Work within an international and diverse team environment.
• Annual performance-based bonus.
• Coverage including personal accident and business trip insurance.
• Additional health insurance benefits.
• Fully remote/home-based work setup supported.
• Attractive referral bonus program.
• Allowance to support remote workplace setup.
• Participation in team building activities, global meetings, and wellness events.

Additional Information

The position can be based in any European Union country. All applications must be submitted in English.