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 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
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 project
*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.
You will have excellent verbal and written communication (English and local language) combined with excellent computer skills; Excel and Access skills preferred and 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.
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.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment