16 Signal Management Jobs

Role Overview: As a PV Physician at Dr. Reddy's Laboratories Ltd., you will be primarily responsible for overseeing and providing medical input for benefit-risk assessment activities. Your role will involve ad hoc data analysis, preparation and review of aggregate reports, signal detection and evaluation, support for benefit-risk evaluation efforts, and more. Your contribution will be crucial in ensuring the safety and efficacy of pharmaceutical products. Key Responsibilities: - Ensure quality control of medical assessment of individual case safety reports, including coding, seriousness, expectedness, and company causality assessments conducted by the vendor. - Contribute to scheduling of ag...

TCS is Hiring -Clinical Safety Physician location - Mumbai, Noida, Bengaluru Experience Range - 5 to 10 Preferred Educational Qualification for the role - MBBS/MD Job Description Literature Review Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports). Provide MAH comments for selected literature Review of Literature Strategy Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses. Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic). Review and interpretat...

TCS is Hiring -Clinical Safety Scientist location - Mumbai, Noida, Bengaluru Experience Range - 5 to 10 Preferred Educational Qualification for the role - Any life science Graduate Job Description Literature Review Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports). Provide MAH comments for selected literature Review of Literature Strategy Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses. Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic). Revi...

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible fo...

As a Drug Safety Specialist specializing in Safety Surveillance and Risk Management at Biocon Biologics, you will play a crucial role in ensuring the safety of our products by managing safety signal activities, developing risk management plans, overseeing aggregate report preparation and submission, responding to safety inquiries, and supporting clinical trial pharmacovigilance activities. You will be a key leader in monitoring safety compliance, influencing stakeholders, and serving as a subject matter expert on global safety regulations and guidelines. Your responsibilities will include supporting the signal management process, evaluating safety data, preparing Risk Management Plans, respo...

JOB DESCRIPTION: JD: Serve as the company's subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and pro...

You should have a comprehensive understanding of AV technologies, including control systems like Crestron, Extron, and AMX programming and configuration, audio systems such as Shure, Sennheiser, and DSP processors like Biamp and QSC, video systems like LED and LCD video walls, projection systems, video-over-IP technologies, and matrix switchers. Knowledge of Unified Communications and Collaboration (UCC) and its integration with platforms like Microsoft Teams, Zoom, and Cisco Webex is essential. You should also be familiar with signal management technologies such as HDBaseT, HDMI, DisplayPort, and IP streaming protocols. Proficiency in design tools like AutoCAD, Visio, and AV design software...

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...