Job ID 211305BR
Position Title Pharmacovigilance Expert
Division Global Drug Development
Business Unit CMO & PATIENT SAFETY GDD
Country India
Work Location Hyderabad
Company/Legal Entity Nov Hltcr Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description 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.
Ø Performs
single case medical review in the safety database or on line listings Of
Oncology marketed products.
Ø Author or
co-authors the medical sections of PSURs including literature review and
analysis of known and potential risks defined in the RMP.
Ø Assists in
the preparation of other safety documents, as needed/required, including Annual
Safety Update Reports (ASR) , DSURs, Core Data Sheets (CDS) and IBs.
Ø Quality of
work delivered (attention to details, thoroughness, medical sound judgment, writing)
Ø Writing of
precise queries allowing for quality data in response
Ø Timeliness
of deliverables according to established directives
Ø Compliance
with Internal and external regulations and procedures
Ø Level of
independence
Minimum requirements
Ø Bachelor of
Science in Pharmacy /Bachelor of Science in Nursing / Pharm D/ or Medical Degree
(MBBS or MD) Good knowledge/fluency in English. Knowledge of other languages
desirable.
Ø 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
Ø Experience
in safety docusment or medical writing including experience coding with MedDRA
and WHO dictionaries in preparation of these reports preferred
Ø Excellent
understanding of clinical trial methodology, GCP and medical terminology
Ø Attention to
detail and quality focused ability to operate effectively in an international
environment
Ø Excellent
understanding of physiology, pharmacology, and the drug development process
including its interactions with HAs
Ø Strong
technical and problem solving skills
Ø Ability to
work independently, under pressure, demonstrating initiative and flexibility
through effective innovative leadership ability.
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