Medical/Clinical Safety Specialist

1 month, 1 week ago
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001

Description

  • Process individual case safety reports (ICSRs) and serious adverse events from clinical trials, including database entry, tracking, narrative writing, follow-up requests, quality checks, and reporting.
  • Perform reconciliation of safety data.
  • Represent safety and pharmacovigilance in project and study team meetings.
  • Plan, coordinate, and quality review aggregate safety reports and support preparation and submission of regulatory safety documents such as DSURs and 6MLL.
  • Oversee local handling, 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 delivery of reports.
  • Serve as the local 24/7 pharmacovigilance contact person or backup for Biomapas and contractual partners.
  • Monitor national and regional pharmacovigilance regulations and ensure compliance.
  • Collect and process medical enquiries received by phone, email, fax, or other channels.
  • Support weekly local or global literature review, safety profile monitoring, signal detection, and evaluation.
  • Participate in inspections and audits, including post-inspection or post-audit support when required.

Requirements

  • University degree in a Life Science field.
  • At least 5+ years of experience in pharmacovigilance, clinical safety, or clinical development.
  • Expert knowledge of pharmacovigilance legislation.
  • Knowledge of international regulations, including ICH, EU GVP Modules, and FDA requirements.
  • Experience with PV databases such as Veeva Vault Safety, Argus, or ArisG.
  • Experience with MedDRA coding.
  • Strong computer literacy.
  • Ability to interpret and apply global drug safety regulations.
  • Fluent English language skills.
  • Willingness to adopt automations and new technologies in daily work.
  • Strong 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 work environment.
  • Annual performance-based bonus.
  • Personal accident and business trip insurance.
  • Additional health insurance.
  • Remote or home-based work.
  • Rewarding referral policy.
  • Workplace establishment allowance for fully remote employees.
  • Team building, global meetings, and B active events.

Interested in this position?

Apply directly on the company website

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