location_onChennai, Tamil Nadu, India
watch_later Posted: Jul 23, 2024
Skills Required
Nice To Have skills
Job Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Roles Responsibilities:
- Review and processing Medical Device Case Reports such as serious adverse events/Serious adverse device effect and Device deficiencies/Device incidence received from various sources Clinical trials, Post Market etc. and other medically related information in Safety database or by completing manual regulatory forms per assigned tasks and study specific procedures for Medical Device Projects.
- Coding Adverse Events in accordance with the applicable standard dictionary (MedDRA and IMDRF)
- Perform or Supervise periodic reconciliation of adverse event and/or quality complaint cases within the required deadlines.
- Quality Control of activity as applicable
- Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- Perform safety review of clinical and diagnostic data for case processing
- Assist with generation of regulatory reports as necessary to ensure regulatory compliance.
- Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues
- Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)
- Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
- Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.
- Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
- Serve as Functional Lead on case processing or medical information projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.
- Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
- Generates data listings from the safety database and assumes responsibility for accuracy of the data.
- Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other Quarterly summary report preparation)
- Supports Safety Scientist in signal detection and risk management activities.
- Supports interim data analysis for DMC reviews.
- Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.
- Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.
- Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
- Proposes solutions for procedural and technical issues.
- Supports audits and inspections as required for the assigned projects.
- Serves as subject matter experts for case processing and/or medical information tasks in a project team.
- Perform other activities as identified and requested by management, including but limited to:
- Respond and process medical information inquiries, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON
- Effectively coaches and mentors less experienced Pharmacovigilance associates.
- Acts as Subject Matter Expert in departmental initiatives.
- Contributes to business development efforts in Device Safety, including presenting safety services at bid defense meetings.
Requirements:
Having knowledge in the Materiovigilance/Medical Devicevigilance such as Medical Device standards ISO 14155; ISO-20916. Guidance: (MDCG 2020-10), MDCG (2024-4) and Individual and aggregate reporting regulations EU MDR 2017/745 and EU MDR 2017/746 and US FDA 21 CFR part 803.
