Chandigarh, Punjab, India
Job Purpose:
- Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
- Signal detection/analysis/evaluation and ongoing safety surveillance activities
- Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety
- Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)
- Provide medical, safety input and review of all required safety reports, Benefit Risk Assessment, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert Statement, Investigator notification letters
- Function as pharmacovigilance representative/safety scientist
Skills:
- Excellent interpersonal, verbal and written communication skills
- Review of literature for product safety assessment and potential safety issues
- Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learnings
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
- Willingness to work in a matrix environment and to value the importance of teamwork
- Strong knowledge of international drug regulation including GCP, GVP
Knowledge and Experience:
Good knowledge of medical terminology.
Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.
Education:
Graduation/Post Graduation in Medicine.
Apply here: https://jobs.parexel.com/en/job/chandigarh/drug-safety-physician/877/66648411488