Remote Pharmacovigilance Specialist - Global Safety Expert

Biomapas Group; Polska; Remote; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Remote work

Annual bonus

Health insurance

Accident & travel insurance

Vaccinations

International team

Team meetings

Job summary

Biomapas Group is expanding its Pharmacovigilance team. We seek a Pharmacovigilance Specialist to ensure compliance with QoL standards and regulatory requirements across global safety information activities.

The role covers safety data processing, literature monitoring, and collaboration with cross-functional teams in a fully EU-based remote setup. The ideal candidate has a Life Science degree, 4+ years in pharmacovigilance, and proficiency with PV databases and MedDRA coding, plus fluency in

Qualifications

• University degree in 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.

Responsibilities

• Responsible for processing of IC SRS, 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

Skills

Attention to detail

Time management

Problem solving

Fluent English

Project management

Education

University degree in Life Science

Tools

Argus/ArisG PV databases

MedDRA coding

Job description

Biomapas Group is expanding its Pharmacovigilance team. We seek a Pharmacovigilance Specialist to ensure compliance with QoL standards and regulatory requirements across global safety information activities.

The role covers safety data processing, literature monitoring, and collaboration with cross-functional teams in a fully EU-based remote setup. The ideal candidate has a Life Science degree, 4+ years in pharmacovigilance, and proficiency with PV databases and MedDRA coding, plus fluency in