Covance Hiring Lead Safety Science Specialist Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry Apply Now
Job Overview:
Manage the
receipt and processing of all adverse event reports reported either
spontaneously from any source or from a clinical trial. This includes, but is
not limited to:
entry of
safety data onto adverse event database(s) and tracking systems
review of adverse
events for completeness, accuracy and appropriateness for expedited reporting
write patient
narratives
code adverse
events accurately using MedDRA
determine
expectedness/listedness against appropriate label
identifies
clinically significant information missing from initial reports and ensures its
collection
ensure case
receives appropriate medical review
prepare
follow-up correspondence consulting the medical staff accordingly.
ensure all
cases that require expediting reporting to worldwide regulatory agencies are
processed swiftly and appropriately within required timelines
reporting of
endpoints to clients, regulatory authorities, ethics committees, investigators
and Covance project personnel, if required, within study specified timelines
provide independent
QC of AE reports for other members of the group
Education/Qualifications:
Degree
preferred to be in one or more of the following disciplines: Biological
Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
Relevant
experience includes experience in the pharmaceutical, biotechnology, or CRO
industry, partly in related areas such as Medical Affairs, Clinical Data Entry
and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or
Quality Assurance.
Experience:
5+ years of
strong clinical drug safety experience
Mentoring
experinece is an added advantage
Good verbal,
written and presentation skills.
Good
communication.
Ability to
interact and influence with line and middle management, staff and external
contacts on a functional and tactical level.
High degree
of accuracy with attention to detail.
Functions as
a team player.
Ability to
present and share useful business information across departments and functions.
Ability to
anticipate and identify problems and take appropriate action to correct
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