Technical writer

Vision Beyond Resources India Private Limited

1 - 4 years

3 - 6 Lacs

bengaluru

Posted:2 days ago| Platform:

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Skills Required

training coding meddra standard operating procedures clinical trials regulatory compliance pharmacovigilance management drug safety monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for an experienced

Medical Reviewer

specializing in

Pharmacovigilance and Drug Safety

to ensure high-quality medical assessment and regulatory compliance of

Individual Case Safety Reports (ICSRs)

and drug safety documentation.

Key Responsibilities:

Conduct
medical review of ICSRs
, including spontaneous reports, literature cases, and clinical trial data, in adherence to client
Standard Operating Procedures (SOPs)
.
Monitor
drug safety updates
and communicate necessary changes to
pharmacovigilance teams
involved in clinical trials.
Ensure
accurate case coding
following MedDRA guidelines and regulatory compliance.
Perform
retrospective reviews of ICSR line listings
within defined timelines.
Train
Drug Safety Associates (DSAs)
on submission guidelines and labeling aspects of cases.
Draft and deliver
safety packages
to clients, ensuring timely
SUSAR submissions (7-15 days)
.
Address queries from DSAs regarding
MedDRA coding, labeling, and narrative reporting
.
Review
eCRFs
for protocol-defined criteria, including events of special interest, endpoints, and sentinel events.
Required Skills & Expertise:
Expertise in Pharmacovigilance & Drug Safety
with a strong background in
PSUR and medical review
.
In-depth knowledge of
MedDRA coding guidelines
and regulatory compliance requirements.
Hands-on experience in
clinical trial safety monitoring
and
ICSR assessments
.
Strong
communication and collaboration
skills for client interactions.
Experience in
training and mentoring Drug Safety Associates (DSAs)
.
Ability to
work under strict timelines
and manage regulatory submissions efficiently.

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