ICON Clinical Research Senior Drug Safety Physician in Warsaw, Poland
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.