Senior/Lead Medical Reviewer Navitas Life Sciences

1.0 - 5.0 years

0 Lacs

karnataka

On-site

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible for developing and distributing project-specific slides, participating in audits and inspections, maintaining trackers, and ensuring team members complete necessary training. Additionally, you will be involved in authoring and reviewing various reports such as RMPs, DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports. Your expertise will be crucial in finalizing these reports and resolving any arising issues, as well as supporting the drafting and implementation of SOPs or WIs. You will act as a point of contact for the aggregate team and clients, assist other teams as needed, and ensure team compliance in report delivery. Desirable Skills and Experience: - Proficiency in medical and Pharmacovigilance terminologies - Knowledge of GCP, GVP, ICH, USFDA guidelines, and other relevant regulations - Basic understanding of medical and therapeutic terminology - Familiarity with patient safety regulatory obligations - Good command of written and spoken English, additional languages are advantageous - Proficiency in MS Office applications (Word, Excel, PowerPoint) - Strong soft skills, including motivation, communication competence, organizational skills, reliability, commitment, and teamwork capacity Location: Bangalore, India Education: Graduate or Post-Graduate in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, or related fields Position: Associate Department: Pharmacovigilance and Safety Employment Type: Full Time,

Posted 5 days ago

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