Senior Drug Safety Physician
About the role
This vacancy has now expired. Please see similar roles below...
This
is an exciting opportunity to work within a fast paced, busy environment for a
leading global provider of outsourced development services to the
pharmaceutical, biotechnology and medical device industries. As a Senior DSP
you will provide medical and safety support to the activities of ICON Project
Teams in order to ensure that projects are conducted according to the highest
ethical principals and medical standards, in accordance with GCP and good
pharmacovigilance practices and in compliance with applicable legal and
regulatory standards. You will also assume the responsibilities of back-up QPPV
or QPPV, depending on experience.
Overview of the role
·
Review of coding (e.g. MedDRA) and accurate assessment
(seriousness, expectedness, listedness, relatedness) of Adverse Events (serious
and non-serious) and of Adverse Drug Reactions (serious and non-serious)
·
Provide support to the Drug Information
&Pharmacovigilance Product Support (call) Centre and the related
projects, including provision of the Product related information to the callers
as well as review and assessment of reported adverse reactions
·
Review of aggregated reports (e.g. patient profiles, line
listings, IND annual reports, Annual Safety Reports, Periodic Safety Update
Reports) in terms of Product safety profile
·
Provide assessment of safety issues arising in clinical trials
or in the post-marketing setting and escalate those to the line manager within
ICON
·
Provide support/training in all aspects of regulatory
requirements for expedited and periodic reporting of AEs/ADRs originating from
clinical trials, post-authorisation studies, spontaneous reporting and
literature
·
Review and provide input to the Project Specific Procedures and
participate in project related meetings
·
Communicate with the client to an extent as described in the
Project Specific Procedures
·
Provide assistance in the preparation and conduct of code-break
activities
·
Review and use of Clinical Trial Protocols, Product Information,
Company Core Data Sheet and any other product related information needed in the
course of assigned projects
·
·
As back-up QPPV/QPPV you will have to
·
- Establish
and maintain the marketing authorisation holder's pharmacovigilance
system;
- Promote, maintain
and improve compliance with the legal requirements;
- Have
access to the pharmacovigilance system master file (PSMF)
- Ensure and
vrify that the information contained in the PSMF is an accurate and
up-to-date reflection of the pharmacovigilance system under the QPPV's
responsibility;
- Have an
overview of medicinal product safety profiles and any emerging safety
concerns;
- Have
awareness of any
conditions or obligations adopted
as part of the marketing authorisations and other commitments relating to safety
or the safe use of the products;
- Have
awareness of risk minimisation measures;
- Be aware
of and have sufficient authority over the content of risk management
plans;
- Be aware
of post-authorisation safety studies requested by a competent authority
including the results of such studies;
- Ensure
conduct of pharmacovigilance and submission of all
pharmacovigilance-related documents in accordance with the legal
requirements and GVP;
- Ensure the
necessary quality, including the correctness and completeness, of
pharmacovigilance data submitted to the competent authorities in Member
States and to the Agency;
- Ensure a
full and prompt response to any request from the competent authorities in
Member States and from the Agency for the provision of additional
information necessary for the benefit-risk evaluation of a medicinal
product;
- Provide
any other information relevant to the benefit-risk evaluation to the
competent authorities in Member States and to the Agency;
- Provide
input into the preparation of regulatory action in response to emerging
safety concerns (e.g. variations, urgent safety restrictions, and
communication to patients and healthcare professionals);
- To act as
a single pharmacovigilance contact point for the competent authorities in
Member States .
Role Requirements
·
Medical Degree from an accredited institution of Medical
education
·
The successful candidate will ideally have 1 or more years of
clinical research or industry experience and at least 1 year of experience as
back-up QPPV.
·
You will have excellent verbal and written communication
(English and local language)
·
Excellent computer skills including Microsoft Office
applications
·
Familiarity with safety databases (e.g. ARGUS, ARISg)
·
Basic presentation skills
Benefits of Working in ICON
Other
than working with a great team of smart and energetic people, we also offer a
very competitive salary and benefits package that includes an excellent pension
scheme, private health care, life assurance and staff recognition
schemes. This varies from country to country so a dedicated recruiter
will discuss this with you at interview stage.
We
care about our people as they are the key to our success. We provide an open
and friendly work environment where we empower people and provide them with
opportunities to develop their long term career.
What’s Next
Following
your application you will be contacted by one of our dedicated recruiters and
if successful we will be able to provide you with more details about this
opportunity.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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