ICON plc Hiring Drug Safety Physician
A rare chance has emerged for qualified physicians as ICON plc opens its doors for a Drug Safety Physician position in Chennai, Tamil Nadu. This opportunity invites medical professionals with 2-3 years of clinical experience to join a leading organization in the healthcare sector.
About ICON plc:
ICON plc is a global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. The company is dedicated to advancing clinical research and improving patient outcomes through innovative solutions. With a strong presence in Chennai, ICON plc is committed to fostering a culture that values high performance and nurtures talent.
Job Details:
- Position: Drug Safety Physician
- Location: Chennai, Tamil Nadu
- Experience: 2–3 years of patient diagnosis and treatment experience in a hospital-based setup
Job Description:
- Drug Safety Physician to 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 principles and medical standards, in accordance with GCP and good pharmacovigilance practices and in compliance with applicable legal and regulatory standards.
- 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)
- 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 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
Eligibility Criteria for Drug Safety Physician:
- Qualified and licensed physician (MBBS or equivalent)
- 2–3 years of patient diagnosis and treatment experience in a hospital-based setup
Additional Information:
ICON plc offers competitive salary packages, annual bonuses based on performance, and a range of health-related benefits for employees and their families. The organization also provides competitive retirement plans and life assurance, ensuring that employees can plan for their future with confidence.
This is an excellent opportunity for qualified physicians to join ICON plc in this drug-safety role and contribute to the advancement of healthcare solutions. Interested candidates are encouraged to apply before the deadline to secure their chance to be part of this esteemed organization.
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