Open vacancy
Senior Pharmacovigilance Specialist
- Yerevan, Armenia
- Full-time
- Senior Pharmacovigilance Specialist
We seek an experienced Senior Pharmacovigilance Specialist to join our dynamic and fast-growing team. You will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed products, ensuring compliance with regulatory guidelines and completeness of documentation.
Responsibilities:
- Conduct the review of all domestic and foreign safety adverse events (SAE) reports for all investigational and post-marketed products to make sure all important SAE elements are provided,
- Ensure consistency in the initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy, and eligibility,
- Draft case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed,
- Perform quality reviews of completed SAE reports, transmit reports to business partners per timelines in safety data exchange agreements,
- Exercise judgment and apply knowledge of FDA, EMA, and ICH guidelines and product labeling in performing SAE case assessments of expectedness,
- Collaborate with cross-functional teams, Clinical Operations, Data Management, and Biostatistics,
- Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed,
- Guide the team with other SAE reporting and Pharmacovigilance Operations,
- Handle all the safety-related issues and potential trends and or signals arising from the review of pre and post-marketed safety data,
- Assist in developing Safety forms, standard operating procedures, and process guidelines,
- Assist in signal detection activities and provide line listings for review,
- Support and participate in audits and inspections, including preparation activities,
- Conduct literature searches to ensure the most current and appropriate literature is cited in the materials and to maintain product expertise,
- Review published scientific literature for ICSRs pertinent to products.
Requirements:
- A bachelor’s degree in Medicine is required,
- At least 3 years of drug safety experience,
- Experience in SAE case processing and working with safety databases,
- Knowledge of MedDRA and WHO Drug coding,
- Proven knowledge of Good Documentation Practices,
- Proficient in MS Office,
- Excellent written and verbal communication skills; fluent in medical terminology,
- Excellent English skills, both written and verbal,
- Good presentation skills,
- Ability to interpret and follow regulatory guidelines,
- Ability to multi-task and balance day-to-day drug safety operations and project work with tight timelines,
- Willing and able to work independently and in a collaborative team setting.
Additional information
If you are interested in this position, please apply now by sending your CV to [email protected], mentioning “Senior Pharmacovigilance Specialist” in the Subject Line of your e-mail.
Please note that only shortlisted candidates will be contacted for the interview.