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Post : MedDRA Query Manager
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 postmarketing.
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 exist- ing 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.
Candidate Profile
Clinical background and expertise in MedDRA coding and in all MedDRA dictionary aspects including SMQs is required (PharmD, nurse practictioner, or similar level with clinical experience preferred). Fluent English (oral and written) ≥ 5 years in pharmaceutical company or contract re- search organization, preferably in drug safety or clinical research.
• Expertise in MedDRA coding and in all MedDRA dictionary aspects including SMQs
• Proven ability to work with large cross-functional teams in complex projects. Has demonstrated teamwork, and effective communication skills. Works effectively and is able to establish relationships with other line functions.
Additional Information:
Experience: 5 years
Location : Hyderabad
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Research & Development
Job ID: 221615BR
Last Date: 21st September, 2017
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