A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Group Head - IMS Oncology Pharmacovigilance Expert
Job Description:
1. Performs single case medical review in the safety database or on line listings Of Oncology marketed products.
2. Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP.
3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR) , DSURs , Core Data Sheets (CDS) and IBs.
4. Organize/supervise daily workload, and ensure that compliance is met
5. Provide, when needed PV technical assistance to the PVEs
6. Manage a team of PVEs
Candidate Profile:
• 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safe-ty experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral in managerial capacity
• Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
• Excellent understanding of clinical trial methodolo-gy, GCP and medical terminology
• Attention to detail and quality focused
• ability to operate effectively in an international en-vironment
• Excellent understanding of physiology, pharmacol-ogy, and the drug development process including its interactions with HAs
• Strong technical and problem solving skills
• Ability to work independently, under pressure, de-monstrating initiative and flexibility through effec-tive innovative leadership ability.
• Organizational skills, clear communicator
Additional Information:
Experience: 3-6 years
Location: Hyderabad
Education: MBBS, MD
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 80709BR
End Date: 4th August, 2011
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