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Drug Safety Physician
2 weeks ago
Drug Safety Physician
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Drug Safety Physician to join our diverse and dynamic team. As a Drug Safety Physician at ICON, you will play a pivotal role in overseeing the medical aspects of pharmacovigilance activities, ensuring the safety of investigational drugs and contributing to the advancement of inNvative treatments and therapies.
What you will be doing
- 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 and discuss the agreed approach on resolution with the client
- 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, asses and provide input to Clinical Trial Protocols, Product Information, Company Core
- Data Sheet and any other product related information as required by the client in the course of assigned project
- Provide input and consultancy to the client in the course of generation of the Company Core
- Data Sheet/Core Safety Information and Product Information
- Provide pharmacovigilance consultancy to the client in terms of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
- Provide guidance to Medical and Safety Services staff with regards to the regulatory reporting of adverse event
- Other responsibilities as assigned.
Your profile
- Medical degree (MD or equivalent) with active medical license.
- Board certification or equivalent experience in a relevant medical specialty (e.g., internal medicine, pharmacology).
- Previous experience in pharmacovigilance or drug safety within the pharmaceutical or biotechNlogy industry preferred.
- Strong clinical judgment and analytical skills, with the ability to interpret complex medical data and make informed decisions.
- Excellent communication and collaboration skills, with the ability to work effectively within a multidisciplinary team environment.
What ICON can offer you:
- Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
- In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
- Our benefits examples include:
- Various annual leave entitlements- A range of health insurance offerings to suit you and your family’s needs.- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.- Life assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our
careers site
to read more about the benefits ICON offers.
