Open vacancy
Drug Safety Senior Specialist
- Yerevan, Armenia
- Full-time
- 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.