Medical Advisor
Tata Consultancy Services
- Budapest
- Állandó
- Teljes munkaidő
- Enter reports of drug adverse events from post-marketed or clinical study source to the safety database.
- Provide medical expertise and judgment throughout the case-handling process with medical review of individual cases.
- You will handle non-serious and serious cases according to regulatory requirements, process instructions and standard operational procedures.
- Resolves queries related to pharmacovigilance activities and individual case reports.
- Adhere to global and local procedural documents.
- A Medical or Physician Degree.
- Good knowledge of US and EU pharmacovigilance regulatory requirements.
- Experience in pharmacovigilance practices concerning signal detection and evaluation.
- Knowledge of drug safety and clinical development and ICH/GCP principles.
- The ability to evaluate, interpret and synthesize scientific data.
- The ability to present and critically discuss clinical data in both internal and external discussions.
- Possess User-level IT skills.
Profession