7 Icsrs Jobs

As a Medical Monitor, your primary responsibilities will include: - Monitoring the in-house clinical trials and overseeing CRO medical monitoring of outsourced projects - Developing and reviewing clinical documents such as protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions, etc. - Organizing Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Your secondary responsibilities will involve: - Reviewing Medical Review of ICSRs, Aggregate reports, Signal reports, and Risk Management plans - Reviewing clinical and non-clinical overviews and summaries of CTD - Reviewing medi...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Role Overview: As a Director of Safety Risk Management in the Healthcare/Lifesciences industry, you will work on the drug safety (pharmacovigilance) team, focusing on understanding the end-to-end PV lifecycle. Your expertise in ICSRs, Periodic reports, and Signal Management processes will be crucial. Leading and guiding RMP and aRMM processes, along with interacting with stakeholders, will be part of your responsibilities. Defining processes, utilizing swim-lane diagrams, and staying updated with regulatory changes are key aspects of the role. Key Responsibilities: - Discussing gaps and pain points with business users and translating customer needs into solutions for BRM/RMP and aRMM process...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Classification of references of safety-relevant publications. To keep track of the internal literature ordering process. Data entry of literature reports into the safety database. Pre...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSRs into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomi...

As a Pharmacovigilance Services Analyst at Accenture, you will be responsible for providing Pharmacovigilance & Drug Safety Surveillance services. With 2 to 5 years of experience and educational qualifications in Any Graduation/Bachelor of Pharmacy/Master of Pharmacy, you will play a key role in the management of the Affiliate Mailbox, reconciliation of reports, and performing follow-up attempts for both Serious and Non-serious cases. Your responsibilities will include case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and global regulatory requirements. In this position, you are expected to po...

To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic pr...