Job IDs: 217166BR;
227230BR
Position Title: CDS Manager
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:
ü The CDS
& SD Manager evaluates Safety Signals from various sources and keeps the
core safety information up-to-date (prepares and reviews CDSs) with current
scientific knowledge, including assessments and recommendations made public by
regulatory authorities.
ü Ensures
patient safety through timely and adequate updates of the core safety
in-formation of marketed products.
ü Tracks
signals in the signal management tracking system, and evaluates line listings
and safety information in scientific literature, including reference product
information and regulatory authority communication.
ü Works
closely with affiliates to harmonize labelling, periodically collect compliance
information and prepare management reports.
ü Prepares,
and drives timeliness, volume and high quality of CDS documents
ü Assists in
managing 3rd party providers for the production of CDS and other
documents.
ü Prepares
data packages required by 3rd party providers. Reviews and qualifies CDSs
deliveries from providers.
Minimum requirements:
ü Quality of
work delivered (attention to details, thoroughness, medical sound judgment, and
writing)
ü Timeliness
of deliverables according to established directives
ü Compliance
with Internal and external regulations and procedures
ü High level
of independence
Educational requirements:
ü Health Care
Professional with labelling and ideally regulatory background, i.e.,
Pharmacist, Pharm D,
MD and equivalent
ü Fluency in
English, including medical / pharmaceutical terminology.
ü Knowledge of
other languages desirable and necessary
ü Established
knowledge of, and experience in the EU drug regulatory environment and drug
approval procedures
ü Familiarity
with EU signal sources / regulatory bodies
ü At least 1
year of experience in drug safety/development or closely related areas of
responsibility
ü Experience
of safety document writing
ü Good
negotiation, proactive and performance oriented, project management and
communication skills
ü Fluency in
EU and US regulation
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