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Biomapas

A complete spectrum of Clinical Research, Regulatory Affairs, Pharmacovigilance and Medical Information solutions.

Medical/Clinical Safety Specialist

Location

Hungary

Posted

16 hours ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishVault

Job Description

Medical/Clinical Safety Specialist

Biomapas

• 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

Job Requirements

  • University degree in the Life Science field
  • At least 5+-year’s 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., 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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