Open vacancy

Drug Safety Senior Specialist

We are looking for an experienced Drug Safety Senior Specialist responsible for monitoring and analyzing clinical trial safety data of pharmaceutical products and devices.

Responsibilities:

  • Developing and implementing Safety management plans to minimize the potential for harm associated with drug usage during clinical trials
  • Managing collection, processing, documentation, reporting, and follow-up of all Adverse Events (serious and non-serious) reports
  • Ensuring accurate and consistent transcription, translations, and data entry of all Serious Adverse Events (SAE) from source documents onto safety systems with emphasis on timeliness and quality
  • Identifying all AEs/SAEs and labeling them appropriately for subsequent case assessments
  • Determining the appropriate type of reported causality
  • Coding based on MedDRA and WHO Drug dictionaries
  • Conducting periodic reconciliation of AE/SAEs between the drug safety and clinical trial databases for ongoing clinical studies.
  • Preparing and/or reviewing safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
  • Ensuring that all safety-related activities are conducted in compliance with regulatory guidelines such as FDA, EMA, and ICH/GCP and internal company policies
  • Update/develop company safety-related SOPs to stay always in compliance with regulatory guidelines such as FDA, EMA, and ICH/GCP
  • Develop training plans for junior staff and provide guidance and expertise per need
Requirements:
  • Bachelor’s degree in medicine, pharmacy, or life sciences
  • 5+ years of relevant experience in a pharmaceutical or clinical research
  • organization
  • Ability to multi-task and balance day-to-day drug safety operations and project
  • work with tight timelines
  • Excellent English skills both written and verbal
  • Excellent Russian skills will be an advantage
  • Working knowledge of applicable Safety Databases
  • Knowledge of FDA/EMA clinical research regulatory requirements
  • Knowledge of pharmacological and medical terminology
  • Willing and able to work independently and in a collaborative team setting
  • Attention to detail and accuracy
  • Strong time management skills
  • Strong team management skills
Additional information

If you are interested in this position, please apply now by sending your CV to [email protected],  mentioning “Drug Safety Senior Specialist” in the Subject Line of your e-mail.

Please note that only shortlisted candidates will be contacted for the interview.

Application deadline: March 2nd, 2024