6 Aggregate Reports Jobs

Medical Review aggregate reports (PSUR, PBRER, ADCO & DSUR) and screening of scientific literature for periodic submission as per the Regulations and SOPs. Manage daily workload in conjugation with line manager for aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. Generation and review of SOPs and WIs and execution of company SOPs. Compliance to project guidelines • Execution of Company Standard Operating Procedures Maintain awareness of changes to/new regulations affecting PVG activities. Trains and mentors new medical reviewers in PVG (if required). To carry out necessary administrative duties required for the job. Other duties as assigned by management. Builds and maintains good relationships across functional units and company affiliates. Preferred candidate profile Proficiency in Aggregate Report. Well versed with technical writing requirements for US and EU. Good therapeutic knowledge.

As the Point of Contact person with the Health Authority on safety-related matters, you will play a crucial role in ensuring the implementation and maintenance of Risk Management Plans and Additional Risk Minimization Materials. Your responsibilities will also include handling safety information-related activities, identifying Pharmacovigilance (PV) activities, and implementing Standard Operating Procedures (SOPs). You will be responsible for the implementation of PV Audit and Inspection Readiness, as well as developing training modules and organizing training sessions. Your role will involve planning, processing, and reporting Aggregate Reports to Health Authorities, establishing and maintaining the Quality Management System (QMS), and implementing Pharmacovigilance Agreements. Additionally, you will be responsible for the collection, follow-up, and forwarding of spontaneous, literature, solicited, post-marketing AE cases. Ensuring the submission of single cases from Clinical Trials to local Health Agencies (HA) and Ethics Committees as required, as well as handling Local Market Safety Data Quality and maintaining Local PSMF will also be part of your responsibilities. To excel in this role, you are required to have a University degree (B. Pharm, M. Pharm, or Pharm D) or a Medical Professional degree. You should have 6-7 years of experience working in Regulatory, Clinical Operations, or Medical Affairs within the pharmaceutical industry, with a minimum of 4 years of experience in Pharmacovigilance. At Bristol Myers Squibb, we value diversity and encourage individuals who are intrigued by a role to apply, even if their resume doesn't perfectly align with the requirements. We believe that you could be one step away from work that will not only transform your career but also have a life-changing impact. As part of a supportive culture that promotes global participation in clinical trials, you will have the opportunity to contribute to work that goes beyond the ordinary. Our shared values of passion, innovation, urgency, accountability, inclusion, and integrity empower each employee to apply their individual talents and unique perspectives. The nature and responsibilities of your role will determine your occupancy structure, which includes site-essential, site-by-design, field-based, and remote-by-design jobs. Depending on your role, you may be required to work onsite at your assigned facility either full-time or in a hybrid model. For field-based and remote-by-design roles, the ability to travel and attend meetings as directed is essential. Bristol Myers Squibb is committed to ensuring equal employment opportunities for individuals with disabilities. We provide a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support for employees with disabilities. If you require accommodations during the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. To prioritize the well-being of our employees, customers, patients, and communities, Bristol Myers Squibb strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. We also consider qualified applicants with arrest and conviction records for employment, in accordance with applicable laws. If you reside in Los Angeles County or expect to work from there upon being hired, please review the important additional information provided on this page: https://careers.bms.com/california-residents/. Rest assured that any data processed in connection with role applications will be handled in accordance with applicable data privacy policies and regulations.,

The PV Scientist Manager is responsible for contributing to the planning, preparation, writing, and review of non-medical portions of aggregate reports. Collaborating with affiliates and other internal Amgen partners, the PV Scientist Manager ensures timely deliverables. Additionally, reviewing Adverse Events/Serious Adverse Events from clinical trials is part of the role. Under the guidance of the Global PV Sr. Scientist or Lead, the PV Scientist Manager reviews study protocols, statistical analysis plans, and other clinical study-related documents. They provide input on the design of safety data tables, figures, and listings from clinical studies. Participation in the development of safety-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specifications, attend project meetings, stay updated on regulatory guidance, maintain Aggregate Report Tracker, perform detailed searches on regulatory agency websites, mentor associates, and provide effective communication that leads to operational excellence. To qualify for this role, you should have a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience. An advanced degree is preferred, along with previous experience in the pharmaceutical/CRO industry. Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous. You should possess excellent data interpretation and medical writing skills, strong project management abilities, interpersonal and negotiation skills, and exceptional oral and written communication skills. Knowledge of global, regional, and national document development guidelines, along with proficiency in Microsoft Word, PowerPoint, and Excel, is essential. You should be able to work well in a team, handle pressure, and deliver quality work within tight timelines. Occasionally, you may need to work in different time zones. This position does not have any direct reports and is based in Gurgaon. If you meet the qualifications and possess the required skills and abilities, we invite you to apply for this challenging and rewarding role in the medical-regulatory writing field.,

The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the delivery of quality products within agreed timelines. Collaboration with internal and external clients will be essential, along with tasks such as writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports, and other relevant documents. You will also be responsible for conducting science reviews of aggregate reports produced by PV Associates and ensuring that all document outputs and processes align with client specifications, templates, and style guidelines. Furthermore, the role requires attending project initiation meetings, maintaining awareness of current regulatory guidance and medical information techniques, updating Aggregate Report Tracker, carrying out cases reconciliation periodically, and conducting detailed searches on regulatory agency websites for safety alerts. Mentoring Associates, overseeing training plans, and enhancing the skills of existing team members will also be part of your responsibilities. The ideal candidate should hold a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience, although an advanced degree is preferred. Previous experience in the pharmaceutical/CRO industry is advantageous, along with additional qualifications in medical writing such as AMWA, EMWA, or RAC. Strong data interpretation, medical writing, and project management skills are essential, as well as excellent interpersonal, negotiation, oral and written communication skills. Proficiency in Microsoft Word, PowerPoint, and Excel, as well as the ability to work effectively in a team-oriented environment, are also required. This position may occasionally require working in different time zones as needed. There are no direct reports for this role, and the location will be in Gurgaon.,

Position: Medical Safety Executive Department: Patient Safety Location: Ahmedabad Key Responsibilities Prepare and update Aggregate reports/ safety documents such as PADERs, PSURs, DSURs, RMPs, PBRERs, REMS, signal management documents and others, as applicable. Responsible for generation of applicable line listings from safety database, literature screening for inclusion, as applicable. Review and Identification of case reports and AOIs from literature and regulatory sources, as applicable. Independently creates and maintains Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), PMCF Reports and Summary of Safety and Clinical Performance [SSCP] for medical devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance documents and applicable procedures and templates. Creates and maintains PMS documents (PMS plan, PMSR, PSUR) and Risk management file for medical devices and combination products per Guidelines and company SOPs Maintain awareness of changes to regulations /new regulations affecting pharmacovigilance activities, as applicable. Train and mentor new employees/ existing employees in aggregate reports writing and other relevant pharmacovigilance activities, as applicable. Data retrieval from the safety database and EDC system, as applicable. Generate validated ad-hoc reports as well as periodic reports from the safety database, as requested. Provide inputs into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals), as applicable. Review of safety sections of protocol, clinical safety report etc., if required. Consults/ Communicates with multiple internal and external stakeholders (e.g. sponsor/ client/ medical monitor/ pharmacovigilance physician) to decide on an action and/or additional steps to provide complete narratives to the sponsor/client, as applicable. Conduct active follow-up for clarification and missing case details with reporter (e.g. site / clinical study team / HCP / patients / caregiver / literature authors, etc.), if required. Enter initial and follow-up information in the safety database according to the project requirement, if required. Perform coding for all required medical/drug/device term according to given coding dictionaries and applicable coding guidelines, as applicable. Perform/ co-ordinate expedited and periodic reporting according to project-specific requirements, as applicable. Responsible to maintain project-specific folders at shared drive as per the project requirements. Maintain PV related information and all correspondence in relation to Pharmacovigilance activities with agencies and customers based on signed agreements, as applicable. Participate in audits and regulatory inspections in cooperation with QA, as needed. Review and preparation of SOPs, WIs, Guides, training materials, providing inputs to SOPs, as applicable. Request or raise various templets (ADM, UAM, etc.) as per the requirement. Provide various quality and compliance related data/documents or any other data/ documents/ evidences required for the oversight and management of pharmacovigilance activities, as applicable. Other duties assigned by Manager/ COD Management/ Head - PV / Designee. Qualifications & experience required Scientific Degree required. Advanced degree (M. Pharm, PharmD or PhD) desirable. Preferably over 3 to 4 years of experience working in Pharmacovigilance and/or Materiovigilance well versed with medical terminology Experience working with biopharmaceutical companies or Medical Device companies in the EU/ US regions Experience working on multiple product types such as vaccines, cell and gene therapies or medical devices Good understanding of applicable regulations such as ICH, GVP, MDR, US regulations