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: Pharmacovigilance Leader
Job Description:
1. Monitors the clinical safety of projects/products and responds appropriately
2. Performs medical assessment and related activities for single cases, including collecting addi- tional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications. Medical review of single case reports will be performed by associates possessing medical degree.
3. Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
4. Provides input into responses to inquires from regulatory authorities or health care profes- sionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
5. Provides pharmacovigilance input to initial development of basic prescribing information and is responsible for pharmacovigilance input into updates of this information.
6. Prepares medical input to aggregate clinical safety regulatory reports 7 Provides input to safety profiling and risk management plan 8 Provides guidance as appropriate to Clinical Safety Operations for the coding and causal- ity/expectedness assessment of adverse event reports.
9. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs.
10. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
11. Participates in review of clinical study protocols/reports/other regulatory documents as needed.
12. Provides relevant input for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and CTT meetings as needed.
13. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
Candidate profile:
Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required Medical degree with specialization preferred. Medical degree is e Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) preferred
• 3 years clinical experience postdoctoral requirement:
• At least 3 years in drug development in a major phar- maceutical company including 2 years in drug safety at an operational or medical position
• Proven ability to analyze, interpret, discuss, and represent safety information both in writing and orally.
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory re- ports/submissions involving safety information.
• Experience with (safety or others) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
Additional Information:
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
Job ID: 237114BR
Location: Hyderabad
Last Date: 20th April, 2018
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