Drug Safety Senior Specialist

Job Description:

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