Skip to main content

Required for Pharmacovigilance Manager in Novartis

 

Clinical courses

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 Manager

Job Description
1. Manage collection, processing, documentation, reporting and follow-up of all adverse event (AE) reports and adverse drug reactions (ADR) for all Alcon products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
2. Ensure recording and tracking of receipts/submissions/distributions of Individual Case Safety Reports (ICSR), Serious Adverse Events (SAEs), Investigator Notifications (IN), Periodic Safety Report Updates (PSUR) and Annual Safety Reports (ASR) and ensure reporting/submission/distribution of safety reports/updates/information (e.g. ICSR, SAE, IN, PSUR ASR, changes in risk benefit) to local Health Authorities(HA) according to regulatory requirements.
3. Work with other local stakeholders to ensure accurate processing of safety data.
4. Interact and exchange relevant safety information with local HA, PV associates, other functional groups and third party contractor, if applicable.
5. Survey and monitor national pharmacovigilance regulations and provide update to Management at local, regional and global level.
6. Set up, implement and update local procedures to ensure compliance with procedures and national requirements.
7. If applicable, coordinate execution/implementation of Risk Management Plans/Commitments and ensure related documentation.
8. Process literature cases detected locally.
9. Review safety sections of all local non-interventional study protocols and review the contract (SSW) if a Contract Research Organization (CRO) is conducting the trial, train the CRO associates responsible for the trial.
10. Review marketing program proposals regarding correct terminology, content and establishment of necessary flow of information and control on collection and reporting of adverse event information. Train responsible vendor associates.
11. Assure reconciliation is performed with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential ADRs/AEs resulting from medical inquiries and quality related complaints.
12. Management and maintenance all local relevant PV databases.
13. Ensure timely preparation and submission of KPI reports on ADR/AE and PSUR reporting including identification of root cause(s) for internal and external late reporting inclusive of development and implementation of corrective/preventive action(s) as needed.

Candidate Profile
Bachelor degree in medicine, pharmacy, or bio-science, clinical medicine training English
• Minimum 5 years of working experience in pharmaceutical or medical device companies in PV/medical safety or clinical research (2 years of PV/medical safety experience in a multi-national company setting required)

Additional Information:
Experience: Min. 5 Year
Qualification: B.Pharm/B.Sc
Location:
Bangalore
Functional Area: R&D
Industry Type: Pharma
Job ID: 174959BR
Last Date:
30th October, 2015

APPLY THROUGH RECRUITERS PORTAL>>

See All   Bangalore Alerts   B.Pharm Alerts   M.Pharm Alerts

See All   Other Jobs in our Database

PharmaTutor Magazine- Latest Issues

Subscribe to Pharmatutor Job Alerts by Email