Novotech Drug Safety Associate Registered
Nurse/Pharmacist / scientific degree qualification
About
Novotech
Novotech
is internationally recognised as the leading independent and full service
contract research organisation (CRO) in the Asia Pacific region. We provide a
wide range clinical development services across all research phases and
therapeutic areas; and have been instrumental in the success of hundreds of
Phase I – IV clinical trials throughout the Asia Pacific.
Powered
by the highest quality people, Novotech strives to set the benchmark for both
business and clinical trial performance.
Our
people are one of our key strengths. We value our people and recognise the work
they do. We are lucky to have the best people and talent from across the Asia
Pacific region work together to deliver to clinical trial success for our
clients.
Our
people and those we look to recruit have an attitude of making things happen.
They are problem solvers, driven with a focus on delivering quality,
accountability and a high level of performance.
About
The Position
Due
to continued growth, we are looking for a talented Drug Safety Associate to
join the Medical team based in our growing Bangalore office.
You
will be responsible for complete and accurate case processing of adverse event
reports following company standard operating procedures, internal business
practices and regulatory guidance documents, to ensure compliance with
worldwide safety regulations.
Core
Responsibilities:
Configuring
of applicable safety database with study-specific information
Preparing
study-specific safety management plan and related tools per client
requirements, SOP and guidelines
Case
processing: completion of full case information on the database, including
quality review to ensure accuracy and completeness, triage of incoming cases to
prioritise for daily workflow management, completion of narrative, manual
coding, approval and reconciliation of safety data
Liaison
with medical monitors/drug safety physicians, clients and study teams as
appropriate to clarify appropriate information required for case processing
Prioritisation
of data entry activities for cases by reference to the date of receipt in
accordance with SOPs and guidelines
Processing
adverse event reports and maintaining safety database and tracking systems and
preparing reports for regulatory authorities as required
Required
Qualification(s):
Registered
nurse/pharmacist or with health/biomedical degree or other related scientific
degree/qualification is required.
A
minimum of 2 years safety-related experience in a pharmaceutical company/CRO
environment is required.
Knowledge
and experience in international drug safety-regulatory reporting obligations
and compliance, coding applications, case processing, safety processes and
tools is preferred.
Good
knowledge of medical terminology, ability to write clear, concise, unambiguous
medical text is required.
Ability
to acquire knowledge in different disease and therapeutic areas, fluency in
English, ability to evaluate data and draw conclusions independently, ability
to follow guidelines and procedural documents (experience of working with SOPs)
is preferred
Computer
proficiency and ability to work in specific safety databases (e.g. Argus) is
essential.
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