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Biomapas

Full lifecycle clinical research outsourcing solutions

Pharmacovigilance Specialist - Medical/Clinical Safety

Biology & BiotechUpdated on Nov 12
Full-timeRemote in BulgariaNo salary listed

About the Job

Requirements

  • A university degree in the Life Science field is required.
  • At least four years of experience in pharmacovigilance, clinical safety, and clinical development is required.
  • Expert knowledge of pharmacovigilance legislation is required.
  • Knowledge of international regulations, including ICH, EU GVP Modules, and FDA regulations, is required.
  • Experience working with pharmacovigilance databases such as Argus and ArisG, and MedDRA coding, is required.
  • Ability to interpret and apply global drug safety regulations is required.
  • Fluency in English and the local country language is required.
  • Ability to adopt automation and new technologies in daily tasks is required.
  • Attention to detail, time management, and problem-solving skills are required.

Responsibilities

  • Ensure compliance with the Quality Management System.
  • Participate in the collection, safety review, processing, and reporting of safety information in compliance with applicable global and local regulations and company procedures and guidelines.
  • Process Individual Case Safety Reports and serious adverse events from clinical trials, including safety database entry, tracking, narrative writing, requesting follow-up from sites, quality checks and reviews, and reporting to clients or agencies for assigned projects.
  • Perform reconciliation of safety data.
  • Participate in project and study team meetings as the safety and pharmacovigilance representative.
  • Oversee the planning, coordination, and quality review of aggregate safety reports, and support preparation and submission of regulatory safety documents such as Development Safety Update Reports and 6-monthly line listings.
  • Supervise local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans, and risk-minimization activities.
  • Collaborate with medical teams, safety physicians, data management, IT, and other functions to ensure timely and accurate reporting and report delivery.
  • Act as the company or contractual partners' local pharmacovigilance contact person or backup on a 24/7 basis.
  • Monitor national and regional pharmacovigilance regulations.
  • Collect and process medical enquiries and responses received by phone, email, fax, or other means from any source.
  • Support weekly monitoring of local or global literature reviews.
  • Support continuous safety-profile monitoring, detection of new signals, and evaluation.
  • Participate in inspections and audits, including post-inspection and post-audit support, when required.

Desired Qualifications

  • Project management experience is beneficial.

About the Company

Biomapas

Full lifecycle clinical research outsourcing solutions

Biomapas provides full outsourcing for life sciences, spanning biopharma, medical devices, cosmetics, and food supplements. It handles clinical research, regulatory submissions, and pharmacovigilance across Europe, CIS, MENA, and LATAM throughout the product lifecycle. It differentiates itself by acting as an in-house, dedicated partner with tailored, end-to-end solutions and strong regulatory and pharmacovigilance expertise. Its goal is to help clients bring products to market efficiently and within budget by integrating as part of the client team from development to commercialization.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
Kaunas, Lithuania
Founded
2001

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