Pharmacovigilance Jobs in Novartis Healthcare

By: Pharma Jobs | Views: 11513 | Date: 29-Dec-2018

Novartis Healthcare Pvt. Ltd.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 us one of the most rewarding employers in our field.

Require Pharmacovigilance Leader at Novartis

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 additional 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 inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CO 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 causality/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, 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 - At least 3 years in drug development in a major pharmaceutical 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 reports/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
Experience : 2 years
Qualification : Pharm.D/Ph.D
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : Research & Development
End Date : 20th January, 2019

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Pharmacovigilance Jobs in Novartis Healthcare

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 : Sr. Pharmacovigilance Expert

Job Description
Provide support for medical safety management within the IMS Department, including single case medical review and related activities, aggregate reports including coordination and management of large datasets for analysis purposes, and preparation of responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating procedures and global and local regulatory requirements. Performs signal detection for assigned products in the Empirica Signal tool. Provide input to medical safety aspect for dedicated projects, lead internal management teams such as SPT or SMT.

1.Performs medical review of single cases from all sources, including review of events associated to quality defects
2. Manages or supports the preparation and review of Investigator Notifications (INs) and distributes INs
3. Performs signal detection and signal evaluation activities for assigned products, and SMaRT topic updates
4. Authors or co-authors the medical sections of periodic reports (PBRER, DSURs per project assignment), assists in or leads the preparation of other safety related documents, including Investigator Brochures (IB), Core Data Sheets (CDS), Product Guidance Documents (PGD), Expert Statements, and Responses to Health Authorities inquiries
5. With BSL/PVL’s support, assists in the development, maintenance and implementation of RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures. The Sr. PVE will assume increasingly independent ownership of these processes
6. Regularly and independently contributes to the evaluation and writing of the medical sections of other study deliverables including, but not limited to, clinical overviews, ad hoc Health Authority queries, Drug Safety Product Profile (DSPP), and Drug Safety Update Report (DSUR)
7. Regularly interfaces with the clinical team for safety matters, including follow-up on events of interest, input into site queries regarding adverse events, and updating Team on PVO requirements
8. For tasks assigned by BSL/PVL, acts as the main IMS contact at internal management teams as SPT, SMT, GPT, and for licensing collaborations
9. Supports preparation for and participates on internal safety reviews boards, such as SMT, MSRB, and SIGDET
10. Provides support to BLS/PVL for quality assurance activities, internal audits, and Health Authority inspections
11. Acts as Deputy for product specific PVLs, assuming full responsibility during the deputation period
12. Lead the training and mentoring of newly recruited colleagues by supporting their integration into the PVE role. Note: While the majority of the responsibilities are the same as for PVEs, the primary considerations for Sr. PVE include the seniority, relevant experience and ability to perform major tasks defined in Job Description consistently and independently, with minimal supervision.

1. Quality of work delivered (attention to details, thoroughness, medical sound judgment, and medical writing skills)
2. Writing concise, accurate and quality documents
3. Timeliness of deliverables according to established directives
4. Compliance with Internal and external regulations and procedures
5. High level of independence
6. Effective communication with- and support to- product safety Colleagues and project functions

Candidate Profile : 
Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English. Knowledge of other languages desirable.

• 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral
• 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 methodology, GCP and medical terminology
• Attention to detail and quality focused
• Ability to operate effectively in an international environment
• Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs
• Strong technical and problem solving skills
• Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability

Additional Information:
Job ID: 205337BR
Location: Hyderabad
Division: Global Drug Development
Business Unit: CMO & PATIENT SAFETY GDD
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D

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Novartis Healthcare Pvt. Ltd

Pharmacovigilance Jobs in Novartis Healthcare Pvt. Ltd

Location: Hyderabad / Secunderabad

Experience: 3 to 6 yrs. Posted on: 16 Aug

Job Description

Provide support to the IMS Department in the single case medical review and associated activities as needed such as Periodic Safety Update Report (PSUR), coordinating the management of large datasets for analysis purposes, responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating proce-dures and global and local regulatory requirements. 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.
Salary:

Not Disclosed by Recruiter

Industry:

Pharma / Biotech / Clinical Research

Farea:

Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:

R&D

Role:

Clinical Research Manager

Keyskills:

Pharmacovigilance ExpertPharmacovigilanceclinical research medical writing drug developmentphysiology pharmacology

Desired Candidate Profile

Education:

UG - B.Sc - Any Specialization, Nursing, B.Pharma - Pharmacy, MBBS - Medicine
PG - M.S/M.D - Any Specialization
Doctorate - Doctorate Not Required

Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical Degree (MBBS or MD) Good knowledge/fluency in English. Knowledge of other languages desirable. 3-6 years prior experience in clinical research or its equivalent with a minimum of 3 years of drug safety experience preferred. May be a first job in the pharmaceutical industry for an MBBS/MD with 3 years clinical experience postdoctoral 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 methodology, GCP and medical terminology Attention to detail and quality focused ability to operate effectively in an international environment Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs Strong technical and problem solving skills . Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.

Company Profile

Novartis Healthcare Pvt. Ltd.
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 us one of the most rewarding employers in our field.

Contact Details
Recruiter Name:

HR

Contact Company:

Novartis Healthcare Pvt Ltd


Contact Details
Recruiter Name:

HR

Contact Company:

Novartis Healthcare Pvt Ltd


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Comments
ahmed  |  24-Aug-2014 06:04:02 IST
I am freshly graduated from faculty of pharmacy.MY English is good.Even though my experience isn't enough for job but I am hardworking person and ready for working under any difficult circumstances . I 'd be grateful if you reply me up.
akriti mishra  |  11-Sep-2014 10:23:49 IST
hello sir / mam ,
i am akriti i am graduate in biotechnology and complete MBA (operation ) and i have six month experience in SCM & quality and i am keen interested to work in to Novartis Healthcare Pvt. Ltd.
RAKESH SOLANKI  |  31-Jan-2017 01:57:13 IST
Working as RSM in ahmedabad, covering GUJ. Total 13yr pharma field experience in neuro-psy, gyn, ped, nutrition and general segment. Age 38.
9979861244
Rohit Arora  |  31-Jan-2017 07:19:25 IST
I am a registered pharmacist with over 18 years experience as a retail pharmacist. I have done D. Pharma and BSc(Zoo). I have been actively involved in healthcare, both in India and US and have also been a part of healthcare recruitment for UK Healthcare. I have an aptitude for Healthcare and want to scale new heights. With over two decades of exposure in this industry, I would like to present myself for this role.
PANKAJ LUTHRA  |  31-Jan-2017 23:04:54 IST
Working as ABM in multinational company covering Punjab, J&K from last 5 years.
Total pharma Experience 24 years + in Diabetic,cardiac& neuro psy field.
9316201081
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