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Biomapas

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

Pharmacovigilance Specialist – Post-marketing and Clinical Safety

MarketingMarketingFull TimeRemoteSeniorTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Greece

Posted

95 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Pharmacovigilance Specialist – Post-marketing and Clinical Safety

Biomapas

• Process ICSRs and Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, case narrative writing, ensuring data completeness, requesting follow-up from sites, quality checks/reviews, submitting expedited safety reports to regulatory authorities and partners, cross reporting, compliance tracking and reporting for assigned projects) • Input in Safety management plan preparation and safety training conduct • 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, PV technology group, 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 clinical safety questions • Ensure the survey and monitoring of national/regional pharmacovigilance regulations • Support weekly monitoring of local or global literature reviews, case intake, and safety database data entry when needed • Support continuous safety profile monitoring, detection of new signals and evaluation • Participate in related inspections 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 related to safety in clinical trials and postmarketing pharmacovigilance (ICH, EU GVP Modules, FDA, others)
  • Experience working with PV databases (e.g., Veeva safety database, and/or Argus and/or ArisGlobal) including case processing, safety outputs and reports preparation
  • MedDRA coding experience withing safety databases and manual for AEs
  • 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
  • Influenza vaccines
  • Rewarding referral policy
  • Workplace establishment allowance (fully remote)
  • Team building, global meetings, B active events

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