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Company Name : PPD
Location : Hyderabad, Telangana
Job Description : JOB DESCRIPTION
Provides medical oversight of pharmacovigilance activities to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at sponsor meetings, provides medical and pharmacovigilance consultation to clients and project team members. May also support business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR with focus on triage, seriousness, expectedness, causality assessment, appropriate selection of adverse event terms using MedDRA terminology, narrative review and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labelling reconciliation documents, CTD modules, REMS, RMP, and CSR). Identifies and investigates safety signals and contributes to the management of the benefit-risk profile of assigned products.
Manages all medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle.
Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues, client SOPs/directives, project specific WPDs for assigned projects and PPD’s corporate policies and SOPs/WPDs.
Provides medical consultation to team members and communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
Provides therapeutic training and protocol training on assigned studies, as requested.
Assists in writing (interpretation of safety data) and/or review of the safety portion of the CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, scientifically reviews aggregate reports, contributes to label updates, review and assessment of literature, supports dossier maintenance and risk management activities etc. to ensure that the medical content is accurate and complete.
Provides medical review of cases and performs review of adverse events of special interest, and serious adverse events.
Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.
Knowledge, Skills and Abilities:
Clinical expertise with attention to detail, quality, and patient safety
Excellent medical knowledge of physiology and pharmacology, understanding of clinical study objectives and overview of the complete drug development process
Great multi-tasking abilities, technical, analytical, organizational, and problem-solving skills, excellent oral and written communication skills, and presentation skills
Ability to work independently and under pressure, analyse work with attention to detail, process and prioritize sensitive complex information • Proficiency in basic computer applications
Fluent in spoken and written English, Excellent interpersonal, influencing and team building skills and Good understanding of FDA, ICH, EMA and GCP guidelines
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
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