Job ID 221615BR
Position Title MedDRA Query Manager
Division Global Drug Development
Business Unit CMO & PATIENT SAFETY GDD
Country India
Work Location Hyderabad
Company/Legal Entity Novartis Health
care Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description Manages the
entire process of creation, maintenance and retirement of standardized Novartis
MedDRA Queries at Novartis; leads and coordinates the cross-functional MedDRA
team (CMT); interacts with medical safety physicians and clinical teams.
Supports the activities involved in the regular MedDRA updates done twice a
year including the official Standardized MedDRA Query (SMQ) updates and
releases (e.g. informing all CMO&PS MedDRA users of the most important
changes etc.).
1. Chairs the the cross-functional MedDRA team
(CMT) which approves all new Novartis MedDRA queries (NMQs), updates of
existing ones as well as retirements of NMQs. In this function plays a central
role in the creation and maintenance of NMQs at Novartis which are essential
for consistent risk definitions, within and across Therapeutic Areas, during
development and post marketing.
2. For NMQ creation: reviews the MedDRA term lists
received from the NMQ requestor, proposes additional terms as appropriate; checks
whether the requested NMQ is already available as standardized MedDRA query
(SMQ or NMQ), provides support in naming and structuring the NMQ (e.g. SOC
assignment).
3. For NMQ maintenance: for routine updates of
already existing NMQs, checks the list of new Preferred Terms (PTs) that
becomes available with the next MedDRA version, proposes which PTs need to be
included in existing NMQs; for scientific / medical content changes of an existing
NMQ, checks the proposed MedDRA term list for possible additional terms to be
added.
4. For NMQ retirement: with each new MedDRA
version, checks if existing NMQs can be replaced by newly released or revised
SMQs. Communication: all TAs (including TASL, BSL, PVL and RMP managers) need
to be informed about a planned retirement of an NMQ.
5. Prepares the finally agreed term list of an NMQ
in a pre-defined structured format for upload in the Novartis Thesaurus
Management System (TMS).
6. Serves as the primary contact for MedDRA search
definitions within Novartis: serves as a central communication point for all
users of NMQs within Novartis.
7. Supports the activities involved in the regular
MedDRA updates done twice a year (e.g. training, update of term lists,
repointing of deactivated terms as appropriate). Informs all CMO&PS MedDRA
users of the most important changes applying to Standardized MedDRA Query (SMQ)
releases and updates.
Ø MedDRA search definitions are up to date, used across
programs, and represent the opinion of the Cross Functional MedDRA Team.
Ø Requests for additional search terms are made to Novartis
MSSO contact person in a timely manner
Ø NMQs are appropriately uploaded in TMS and retired as
required.
Minimum requirements
Ø Clinical background and expertise in MedDRA coding and in
all MedDRA dictionary aspects including SMQs is required (Pharm D, nurse practitioner,
or similar level with clinical experience preferred).
Ø Fluent English (oral and written) ≥ 5 years in
pharmaceutical company or contract re-search organization, preferably in drug
safety or clinical research.
Ø Expertise in MedDRA coding and in all MedDRA dictionary
aspects including SMQs
Ø Proven ability to work with large cross-functional teams
in complex projects. Has demonstrated team work, and effective communication
skills.
Ø Works effectively and is able to establish relationships
with other line functions.
Last date to apply: 21st September, 2017
To Apply online CLICK HERE
For more updates follow at PHARMACOMPANION
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