Biomapas

Clinical Specialist

• 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

Medical/Clinical Safety Specialist

General

• Act as a Local Safety Officer and Medical Information Specialist in Romania (nomination as per local requirements)
• Communicate with Health Authorities
• Ensure compliance with applicable local guidelines and regulations
• Collect, process, and communicate of safety information, product quality complaints and medical device incidents
• Maintain and establish quality standards for local pharmacovigilance activities
• Ensure weekly monitoring of local literature review
• Participate in inspection and/or audits
• Ensure the survey and monitoring of national pharmacovigilance regulations
• Receive and handle medical information enquiries from patients and health care professionals

Pharmacovigilance Specialist

• Act as a National Contact Person in UK and North Ireland
• Communicate with Health Authorities
• Ensure compliance with applicable local guidelines and regulation
• Collect, process and communicate of safety information
• Maintain and establish of quality standards for local pharmacovigilance activities
• Ensure weekly monitoring of local literature review
• Participate in inspection and/or audits
• Ensure the survey and monitoring of national pharmacovigilance regulations
• Receive and handle medical information enquiries from patients and health care professionals

• Perform local operations and ensure compliance with safety regulations and procedures
• Manage and share safety information with relevant authorities and clients
• Serve as the main contact for safety matters with authorities and clients
• Ensure timely handling of safety information for products
• Review local literature
• Medical Information Requests handling

• Act as a Local Safety Officer and Medical Information Specialist in Italy (nomination as per local requirements)
• Communicate with Health Authorities
• Ensure compliance with applicable local guidelines and regulations
• Collect, process, and communicate of safety information, product quality complaints and medical device incidents
• Maintain and establish quality standards for local pharmacovigilance activities
• Ensure weekly monitoring of local literature review
• Participate in inspection and/or audits
• Ensure the survey and monitoring of national pharmacovigilance regulations
• Receive and handle medical information enquiries from patients and health care professionals

• Act as a Local Safety Officer and Medical Information Specialist in Spain (nomination as per local requirements)
• Communicate with Health Authorities
• Ensure compliance with applicable local guidelines and regulations
• Collect, process, and communicate of safety information, product quality complaints and medical device incidents
• Maintain and establish quality standards for local pharmacovigilance activities
• Ensure weekly monitoring of local literature review
• Participate in inspection and/or audits
• Ensure the survey and monitoring of national pharmacovigilance regulations
• Receive and handle medical information enquiries from patients and health care professionals

Director

• Join our Pharmacovigilance team as Associate Director International PV.
• Responsible for the leadership and oversight of the international PV office.
• Ensure compliance with international regulations, guidelines, and internal quality standards.
• Oversee and manage a team of EU/UK QPPVs and PV personnel.
• Support operational, financial, and client objectives of the sub-department.
• Drive process excellence and effective management of PV operational activities.
• Influence the performance of the quality system and PV activities.
• Oversee sub department forecasting and contribute to budget planning.
• Manage PV projects and customer activities, supervising core PV deliverables.
• Ensure oversight of the contractual partner safety data exchange agreements.
• Oversee inspection/audit strategy, readiness, and finding remediation.
• Monitor regulatory changes and ensure PV compliance across assigned projects.
• Manage assigned team, set goals, evaluate performance, and support decisions on promotions.
• Identify areas for improvement and proactively propose solutions.

Associate Director – International PV

Research Analyst

• Join our dynamic team at Biomapas as a Clinical Research Associate (CRA) in Ukraine.
• Your role will be crucial in overseeing clinical trials and ensuring that they are conducted in compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Study site monitoring and management (site selection, initiation, monitoring and close-out visits)
• Perform feasibilities and support start-up phase
• Create and maintain required study documentation (site management, monitoring, etc.)
• Ensure that clinical trials are conducted according to requirements (protocol, ICH-GCP, etc.)
• Administer protocol and related study training to assigned sites
• Perform regulatory document review
• Prepare clinical trial documents and store, archive correspondence
• Negotiate study budgets with potential investigators/sites, assist in agreements

Clinical Research Associate

Project Manager

• To oversee and manage strategic/key accounts
• Maintain high quality regular communication with Clients contact persons
• Ensure high quality local performance of countries in scope through effective liaising with Biomapas staff responsible for PV regional management
• Effectively manage a team supporting project management activities
• Manage and track assigned projects invoices
• Oversee project financials and profitability
• Support in developing project management process
• Support in preparations and attendance of bid defences
• Involve in forecasting and project budgeting
• Support team with issue resolution and workflow distribution

Medical/Clinical Safety Specialist

Pharmacovigilance Specialist

Pharmacovigilance Specialist

Pharmacovigilance Specialist

Pharmacovigilance Specialist

Pharmacovigilance Specialist

Associate Director – International PV

Clinical Research Associate

Pharmacovigilance Project Manager