About
Bionika Pharmaceuticals is a pharmaceutical company for production of solid, semisolid and liquid dosage forms. The size and scope of the company has been designed to serve the regional market, respecting the highest standards stipulated by the global pharmaceutical industry. Manufacturing processes, quality control labоratory, microbiology labоratory and R&D laboratory meet the latest requirements of Good Manufacturing Practice (GMP) and Good Quality Control Laboratory Practices, production and quality standards of solid, semi-solid and liquid dosage forms. The warehouse fully meets the requirements of Good Storage Practice.
Pharmacovigilance Operations
Individual Case Safety Report (ICSR) managementSignal detection and evaluationRisk Management Plan (RMP) developmentBenefit-Risk assessmentAggregate report writing (e.g., DSURs, PBRERs)Literature screening and follow-up procedures
Regulatory Affairs & Compliance
PV regulatory intelligence (GVP, FDA, local guidelines)Pharmacovigilance System Master File (PSMF / PSSF)GVP inspection preparedness and survival strategiesLocal and global PV compliance oversightLegal and quality assurance in safety functions
Medical Affairs & Patient Safety
Post-Trial Access (PTA) and ethical safety oversightCollaboration with medical affairs and clinical opsManaging patient-centric safety initiativesIntegrating medical and safety functions
Risk Management & Strategy
Global pharmacovigilance strategySafety governance and cross-department alignmentStrategic risk communication (e.g., DHPCs)Organizational leadership in safety functionsPortfolio-level benefit-risk strategy
Data Science, RWE, and Analytics
Use of Real-World Data (RWD) and Real-World Evidence (RWE)Predictive safety analytics and data modelingEnhancing insights for patient risk profiling
Academic & Research-Oriented Roles
Clinical safety scienceAcademic collaboration in PV researchTraining and education in drug safety