Pharmacovigilance Specialist (Medical/Clinical Safety)
This is the employer's own posting, not a copy on a job board.
What we know
Is it still open?
Confirmed still open
Last checked just now — checked against the employer's own applicant tracking system, which is the company answering directly.
We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.
How old is it?
Posted 18h ago
The date the source published, not the day we noticed it (2026-10-16). Last seen at its source 1h ago.
Is it remote?
Marked remote on the employer's board
Their board carries a remote setting on this posting — a field they filled in, not wording we read. The location field names somewhere specific, which is usually where the team or the entity sits.
Who may apply?
Bulgaria, Croatia, Poland, Romania, Greece
The description states no restriction of its own. This is the source's own tag.
Pay not stated
Similar roles pay $91.6k–183k/yr
Middle 50% of 15 listings that do state pay — Healthcare · all levels · Eastern Europe · USD/year. This employer has published no salary; this is what comparable listings we hold disclose, never converted between currencies or periods. How this is calculated.
Skills named in the ad
Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.
Carried by 1 source
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Workable employer's own board first seen 1h ago · last seen 1h ago
The listing
Join our global Pharmacovigilance team as a Pharmacovigilance Specialist (Medical/Clinical Safety).
Pharmacovigilance Specialist (Medical/Clinical Safety) is responsible for assuring compliance with the Quality Management System. 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.
Position is in any EU country.
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
Requirements
- University degree in the Life Science field
- At least 4+-years’ 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, ArisG) and MedDRA coding
- Ability to interpret and apply global drug safety regulations
- Fluent English and local country language
- Eager to adopt automations and new technologies in daily tasks
- Attention to detail, time-management and problem-solving skills
- Project management experience is beneficial
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