Scholastika Knowledge Base Pvt. Ltd. is hiring a Drug Safety Assessment Subject Matter Expert for a full-time freelance assignment.
Position: Drug Safety Assessment SME
Engagement: Full-time freelance
Required qualifications
Education
Master's degree in one of the following:
- Pharmacology
- Pharmaceutical Sciences
- Clinical Pharmacy
- MPharm or a closely related discipline
Experience
Minimum 2 years of hands-on experience in drug safety and pharmacovigilance, covering one or more of the following:
- Case processing and medical review
- Signal detection and risk evaluation
- Aggregate safety reporting, including PSURs/PBRERs and DSURs
- Clinical-trial safety monitoring and reporting
- Protocol development and feasibility assessment
- Collaboration with clinical operations, data management or medical monitoring teams
Domain expertise
- Strong understanding of regulatory and scientific standards, including ICH,
EMA and FDA guidelines
- Ability to critically evaluate scientific literature, clinical information and safety data
- Sound understanding of clinical-trial and drug-development workflows
General skills
- Excellent written English
- Solid analytical and critical-thinking ability
- Meticulous attention to detail
- Ability to communicate complex scientific concepts clearly and concisely
- Comfortable using digital tools, web-based platforms and structured evaluation forms
Qualified professionals may send their CV to [HIDDEN TEXT] with the subject line: