Drug Safety Job Vacancies in Hyderabad

Role & Responsibilities:1. To own IRL Vision, Values, and Mission.2. The candidate should have excellent knowledge of Biochemical pathways, Cell-based, and Biochemical assays. Good knowledge of platforms like NanoBret, HTRF, AlphaLISA, LCMS-MS-based assays & in-life studies.3. Develop, validate, miniaturize and troubleshoot in-vitro biochemical and cell-based assays 4. A demonstrated record of delivering DMPK and PK/PD expertise, including dose-ranging, formulation, and stability studies for drugs, with the ability to successfully troubleshoot technical challenges5. S(he) should have the ability to manage diverse teams like cell biology and ADME teams. 6. Candidate should have good persuasive speaking skills. The candidate will be responsible for presenting regular scientific updates to clients. 7. The candidate should be curious and willing to do the work client requires8. Responsibility for managing timelines and deliverables 9. A good team player with strong interpersonal skills who shows a willingness to assist other laboratory personnel when required10. An inquisitive and fast learner who keeps abreast with the latest scientific developments in his/her areas of work and related fields.11. Seamlessly connect with the team to review the data carefully. Statistical analysis knowledge, creating data visualizations, and writing reports.Qualifications and Educational Requirements: 1. Ph.D. with a specialization in Pharmacology/ Biotechnology/Biochemistry with 12-15 years of experience in a Drug Discovery CRO space. 2. Experienced in working in and driving a cross-functional matrix. 3. Age will not be a constraint in deserving cases. 4. We are gender neutral.

Quality review of ICSRs, surveillance of known or emerging safety issues, participation in an escalation process, risk evaluation, and analysis of safety data. Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle. Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures. Contributes to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR) Participates in the set-up and maintenance of adverse event processes in global clinical trials Ensure Quality of the Individual Case Safety Report, including data and a concise, medically relevant narrative.