Medical Reviewer- Signal and Aggregate

About Navitas Life Sciences:

Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries.

At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider.

Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry.

Navitas Life Sciences is proud to be an HIG Portfolio company.

Website: www.navitaslifesciences.com

Expereince

Skill Set:

Responsibilities & functions: Medical Reviewer

Aggregate Reports and Risk Management Plans

• Responsible for the implementation of operational tasks in the field of safety writing
• Overseeing the service performance
• Mentoring employees enabling them to work independently within timelines, budget, and quality
• Review the RMP/PSUR or any aggregate documents for medical cohesiveness
• Managing all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements/expectations
• Develops and dispatches project specific slides for both internal and external parties
• Participate in internal and external audits and inspections by clients and health authorities.
• Ensure that all trackers related to NLS and client specific procedures are in place and updated on timely basis.
• Ensures the project team members in completion of all NLS or client specific trainings.
• Conducts trainings as required for improvement of team performance
• As required, authors and reviews RMPs, DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports
• Provides expertise required for the finalization of the RMPs, DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports and its annexes. Resolve issues as they arise. Ensure proper maintenance of all RMPs, DSUR’s, PBRER’s, PSUR’s, PADER’s and Canadian Aggregate Reports
• Supports in drafting and implementation of NLS or client specific SOPs or WIs.
• Provides inputs in client specific guidance documents.
• Acts as Point of contact for NLS aggregate team and client.

Signal Management and Risk Management Plans

• Screening, data mining and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement.
• Generation of line listings and summary tabulations from Argus/client safety database.
• Drafting Signal detection, validation, assessment and benefit-risk analysis and prioritisation of signals by reviewing available data.
• Ensure compliance to appropriate signal SOPs, conventions and guidelines for all activities performed.
• Tracking of identified signals from regulatory and internal signal detection process and monitoring the status of signals: potential signals, open signals, refuted signals and validated signals.
• Developing Risk Management Plans and associated activities as per NLS/client specific SOPs

Other Responsibilities

• Assist or support Individual Case Safety Report team as per the workload in respective teams
• Assist or support Literature review team as per the workload in respective teams
• Assisting in scheduling of reports assigned to the team
• Assis Manager/designee in allocation, tracking of reports developed by the team
• Conduct daily status meetings as required for the projects
• Support in creating/ updating SOPs as required
• Ensure team compliance in delivering the reports

Qualifications & competences:

• Graduate or post graduate degree in life sciences, pharmacy, medicine, dentistry, allied health sciences and any additional related courses.
• Good understanding of medical and Pharmacovigilance terminologies
• Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations
• Basic competence with medical and therapeutic terminology.
• Understanding of patient safety regulatory obligations.
• Should be familiar with regulatory and pharmacovigilance guidelines.
• Good command of written and spoken English; additional languages favourable
• Good knowledge of usual office software (MS Office: Word, Excel, Power point)

Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability commitment and capacity for teamwork).