34 Signal Management Jobs - Page 2

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead for Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include leading, authoring, and finalizing various aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory inquiries. You will also be involved in literature surveillance, signal management activities, and benefit risk management documents. In this role, you will play a key role in setting up, implementing, and leading safety management teams for post-marketing and clinical trial projects. You will be responsible for overseeing signal detection...

As the companys subject matter expert on drug safety and pharmacovigilance, you will be responsible for ensuring compliance with Local & Global PV-relevant Heath Authority requirements. Your role will involve overseeing PV Contracts, vendor management, and PV system audits/inspections. Additionally, you will develop a good understanding of signal management and benefit-risk evaluation activities. You will be expected to develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures. Acting as the primary safety liaison with country regulatory authorities and internal stakeholders will be a key part of your responsibilities. Collaboration with Clinical Development,...

As a Technical Designer - Audiovisual (AV) at Avientek, you will be responsible for designing and implementing customized AV solutions. You will work closely with the sales and engineering teams to create exceptional AV systems for clients, ensuring that they meet their unique requirements. Your technical skills will include a comprehensive understanding of AV technologies, such as control systems like Crestron, Extron, and AMX programming and configuration, audio systems including Shure, Sennheiser, and DSP processors like Biamp and QSC, and video systems like LED and LCD video walls, projection systems, and video-over-IP technologies. You will also need expertise in unified communications ...

The ideal candidate for this position should have 1-2 years of experience in AMS design verification. You will be responsible for developing Verilog/VerilogA/VerilogAMS models for signal and power management modules to support top-level verification. Experience in full chip DV would be an added advantage. You will contribute to the development of the Full-Chip AMS-DV plan and own significant pieces of this verification process. It is essential to have the ability to drive best practices in the field of AMS-DV. In this role, you will work independently to identify bugs and resolve them formally with cross-functional teams. An understanding of analog power IPs will be beneficial as it can help...

Job Description Drug Safety Physician At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commerc...

We are looking for MBBS - Medical Reviewer with 2-3 years of experience in Pharmacovigilance having expertise in review f aggregate reports. Candidate who are willing to come to office and work from office only can apply. Designation : Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 2-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended). Location : Gurgaon (Work from office is must with one-day flexi working option) Job Responsibility Design, develop and maintain procedures for medical rev...

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and c...

Role & responsibilities To prepare and review and reporting of aggregate reports (PADERs and PBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective c...

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 Perfo...