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Biomapas

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Medical/Clinical Safety Specialist

Clinical OperationsClinical OperationsFull TimeRemoteMid LevelTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Poland

Posted

3 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

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.

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