Pharmacovigilance Specialist – Medical/Clinical Safety

This is a fully remote position, open to applicants in Bulgaria, +4 more countries.

📋 Description

• Ensure adherence to the Quality Management System.

• Handle ICSRs and Serious Adverse Events from clinical trials, which includes safety database entry, tracking, narrative writing, site follow-up requests, quality checks/review, and client or agency reporting.

• Conduct reconciliation of safety data.

• Represent Safety and Pharmacovigilance in Project/Study Team meetings.

• Manage the planning, coordination, and quality review of aggregate safety reports.

• Assist in the preparation and submission of regulatory safety documents, such as DSURs and 6MLL.

• Oversee the local handling, preparation, and submission of Periodic Safety Update Reports and Risk Management Plans, as well as risk minimization activities.

• Collaborate with medical and safety physicians, data management, IT, and other departments to ensure prompt and accurate reporting or delivery of reports.

• Serve as the 24/7 local pharmacovigilance contact person or backup for Biomapas and/or contractual partners.

• Keep abreast of national and regional pharmacovigilance regulations.

• Gather and process medical inquiries received via phone, email, fax, or other methods.

• Assist in the weekly review of local or global literature.

• Contribute to ongoing safety profile monitoring, signal detection, and evaluation.

• Take part in inspections and audits, including support following inspections/audits as needed.

⛳️ Requirements

• Bachelor’s degree in the Life Sciences field.

• Minimum of 4 years’ experience in Pharmacovigilance, clinical safety, and clinical development, along with expert knowledge of pharmacovigilance regulations.

• Familiarity with international regulations (ICH, EU GVP Modules, FDA).

• Experience with PV databases (e.g., Argus, ArisG) and MedDRA coding.

• Capability to interpret and implement global drug safety regulations.

• Proficient in English and the local country language.

• Willingness to embrace automation and new technologies in daily tasks.

• Strong attention to detail, time-management, and problem-solving skills.

• Project management experience is a plus.

🏝️ Benefits

• Opportunities for professional growth and career advancement.

• Work within an international team and environment.

• Annual performance-based bonus.

• Personal accident and business trip insurance.

• Additional health insurance coverage.

• Flexibility of remote/home-based work.

• Access to influenza vaccinations.

• Attractive referral policy.

• Workplace establishment allowance for fully remote positions.

• Team building activities, global meetings, and B active events.