Work as Pharmacovigilance Expert @ Novartis Healthcare Pvt. Ltd.
Provide support to the Medical Safety 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 procedures 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.
1.Quality of work delivered (attention to details, thoroughness, medical sound judgment, writing)
2.Writing of precise queries allowing for quality data in response
3.Timeliness of deliverables according to established directives
4.Compliance with Internal and external regulations and procedures
5.Level of independence
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Employment Type: Permanent Job, Full Time
Pharmacovigilance Standard Operating Procedures Pharmacovigilance Expert safety physiology pharmacology Drug development Drug safety
Desired 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.
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