Responsibilities : - Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations. Conduct & review of toxicology risk assessments for excipients, impurities, solvents, extractables and leachables, ensuring adherence to regulatory standards. Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines. Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies. Develop and compile PDE and OEL monographs to support safety evaluations. Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions. Manage preclinical studies and associated documentation to ensure compliance and accuracy. Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines. Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment. Provide expert guidance in addressing client and regulatory inquiries effectively. Background Required - Qualified Toxicologist Signing non-clinical/ toxicological reports/ modules/ expert reports Drafting of Environmental risk assessment reports Due diligence of pre-clinical data and drafting strategy for non-clinical studies for complex generics, NCEs, Biologics etc Drafting and review of non-clinical CTD modules Drafting of PDE reports Toxicological risk assessment of impurities/ leachables/ extractables Required education: Qualified and experienced Toxicologist Required experience : At least 2 years of experience in above mentioned activities.
ProductLife Group is looking for Medical Reviewers, having 3-4 years of experience with MBBS/MD degree. Responsibilities: We are looking for a medical reviewer proficient in post-marketing drug safety. Post-Marketing (Pharmacovigilance) Medical review of the ICSRs (Spontaneous, literature, clinical studies) Support in seriousness assessment, Initial Triage Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. perform additional review of cases to ensure competency. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members on good assessment of the cases and MedDRA coding Required Education: MBBS, or MD (Doctor of Medicine) Required Experience: Client communications Safety Database experience Minimum 3-4 years experience working for service providers or pharmaceutical company in Pharmacovigilance department Additional experience and/or skills:: Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team. Clinical experience an advantage Ability to deliver constructive feedback Emotional intelligence Adaptability Analytical skills Flexibility Reliable Strong organisation skills Punctual Database experience
MISSION: The Case Specialist s job is to guarantee the optimised management of vigilance cases, using their scientific knowledge to enable a detailed analysis of the various files. He/she is the guarantor of the proper handling of a case, both from a regulatory and medical point of view, and in this respect masters the regulations in force. He/she must be able to validate all tasks related to the exploitation of cases, from their collection to their submission. In addition, he/she contributes to the smooth running of his/her Line Of Business. Main activities and technical skills: VIGILANCE CASES: Responsible for the Quality Control (QC) of vigilance cases. The QC includes fields: Coding according to applicable dictionary (MedDRA/IMDRF/Product/WHO or other). Seriousness of the events/effects/incidents . Expectedness/listedness. Data entry of vigilance cases in ad hoc databases or in formats defined with the client. Follow-up request of vigilance cases by phone/mail Suggesting queries to complete the case. Confirm or support Data Officers submission requirements. Validation of documents within the Safety and Vigilance platform. Analysis of inclusion/exclusion for cases received from EV or MHRA ICSR download. Reconciliation activities. MEDICAL INFORMATION: In support of the medical information line of Business Taking phone calls reporting vigilance notifications. CUSTOMER/PROCESS MONITORING: Participation in the operational implementation of new clients. Key contact with clients (with the support of a senior member of staff or the division manager). Drafting/updating of technical agreements /safety management plan / client template (for a trial for example) Drafting/updating of procedures/ operating methods or others directly related to its activity Participation in the implementation/ maintenance/ improvement of processes Additional Activities: Participation in the coordination of Case Management by relaying to the coordinator if necessary. Support for the coordination of activities (including planning and monitoring) ensuring effective communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines. Required Education: BPharm / MPharm Required Experience: 4-5 years Required Technical Skills: Well versed with MS Office, Safety Databasea Additional Skills & Experience: Presentation skills, Communication Skills, Should be well versed with pharmacovigilance basics, case processing and associated conventions, thorough knowledge of GVP modules, ICH guidelines, regulatory requirements, MedDRA coding, well versed with safety databases, solution oriented.
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