2 Gvp Guidelines Jobs

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system in terms of medical review of safety cases and management of safety signals. Key Responsibilities: - Conduct medical review of ICSRs, including assessment of Literature cases and authoring of enhanced MAC. - Support safety lead in authoring medical assessment letters based on the bi-annual/six-monthly line listing. - Perform literature review of assigned articles and assist in the review of articles for inclusion in PBRER, DSUR, IB, etc. - Provide support to Therapeutic Areas as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents. - Assist in monitoring the safety profile of products, including activities such as literature review, medical review of individual cases, and medical evaluation of quality defects. - Co-author the PBRER and provide medical inputs to specific sections, including follow-up activities on HA assessment reports. - Contribute to the medical sections of DSUR, IB, labeling documents, Product Guidance Documents, and Expert Statements. - Support signal detection and evaluation activities for assigned products. - Assist in the preparation of Health Authority queries and other safety-related documents. - Act as a Subject Matter Expert for Medical Function processes and provide support during audits and inspections. - Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities. - Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality. - Assist in the development and optimization of training materials and deliver training to Novartis staff and external stakeholders. Minimum Requirements: - Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in relevant field, or Medical Degree (MBBS or MD) required. - Minimum 3 years of experience in the pharmaceutical industry or related field. - Experience in safety document or medical writing, including proficiency in coding with MedDRA and WHO dictionaries. - Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology. - Attention to detail and quality focus. - Strong organizational and project management skills. - Excellent communication skills and ability to operate effectively in an international environment. - Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. - Technical understanding of Biomedical/Biostatistics concepts and strong problem-solving skills. - Good presentation skills. - Proficiency in computer skills, including creating spreadsheets, templates, presentations, and working with safety databases/applications. - Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.,

Regulatory Reporting Compliance Ensure timely and accurate submission of regulatory reports, including Adverse Event Reports, Periodic Safety Update Reports, and other required documentation Interpret and apply global regulatory reporting requirements including those for health authorities Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards Adverse Event and Safety Reporting Coordinate pharmacovigilance reporting activities, ensuring compliance with Good Pharmacovigilance Practices Work closely with safety teams to assess, process, and submit Individual Case Safety Reports within required timescales Assist in detection and risk assessment activities to client safety protocols Regulatory Documentation & Submissions Prepare, review, and submit regulatory reports, ensuring completeness, accuracy, and compliance within legal requirements Maintain documentation for regulatory audits and inspections Collaborate with cross-functional teams (e.g., Quality Assurance, Medical Affairs, Client PS Teams) to ensure alignment on regulatory reporting requirements Training and Process Improvement Provide training and guidance to GBS internal teams on regulatory reporting obligations and best practices Support audits and inspections by regulatory authorities and implement corrective actions as needed General Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety-related processes and brand activities within countries of remit and being audit and inspection ready. Support external service providers to meet the company and local regulatory PV requirements. Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Regulatory systems, Human Resources systems, Quality Management Systems, and other global or local systems commercial databases as appropriate. Maintain current and in-depth knowledge of: Relevant country regulatory authority regulations Global and local procedural and guidance documents Conditions, obligations, and other commitments relating to product safety or the safe use of AZ products Essential Skills/Experience: Bachelors degree in pharmacy, Life Sciences, Regulatory Affairs, or a related field 3 years + of experience in regulatory affairs, pharmacovigilance or regulatory reporting in the pharmaceutical industry Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority s regulations Cross-functional collaborative approach Effective and lateral thinking Problem-solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Medical knowledge in company Therapeutic Areas Successful participation in above-market projects Audit & Inspection experience