34 Signal Management Jobs

We are looking for MBBS - Medical Reviewer with 0-3 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 : Sr. Research Scientist / Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 0-3 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 p...

Role Overview: You will be leading the Signal Management and Innovation processes at Amgen, working closely with the Integrated Signal Management team to identify, evaluate, and implement emerging technologies and AI/ML-enabled analytical tools. Your role will involve collaborating with various teams to develop innovative surveillance capabilities for monitoring the safety and quality of Amgen products. Key Responsibilities: - Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance. - Maintain a landscape of external vendors offering signal detection, NLP, and data analyti...

As a Medical Safety Expert, your role involves performing medical review of safety reports, triage activities, and signal management activities. You will be responsible for signal detection, validation, prioritization, and assessment, as well as proposing recommendations. Additionally, you will conduct safety evaluation of ongoing signals, safety issues, IRSR, etc. Your tasks will also include reviewing non-ICSR scientific literature from a signal and aggregate report perspective. Key Responsibilities: - Provide safety concerns, search criteria, and literature review for aggregate reports - Conduct medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.) and analyze the benefit...

Role & responsibilities The role requires the individual to support Safety Signal Management by processing of signals of disproportionate reporting and by collation and review of signal evaluation reports. Supporting aggregate reports by medical review of individual case safety reports for assigned periodic reports for various regions around the globe. Details of the responsibilities: 1. Signal Management: a. Processing and Evaluation • Processing of Signals of Disproportionate Reporting (SDRs) Causality assessment of unexpected case occurrences/ SDRs b. Report Generation Drafting of molecule specific Signal Evaluation Reports Drafting of molecule specific Signal Inputs for ADCOs / PBRERs/ P...

Role Overview: As a stand-alone global functional lead at a project level for Safety Aggregate Report and Analytics (SARA) Center deliverables, you will be responsible for overseeing safety aggregate reports, literature surveillance, signal management activities, and benefit risk management documents. Your role will involve actively contributing to Lifecycle Safety global process initiatives and collaborating closely with the safety customer delivery management team to ensure adherence to standard best practices established by the SARA infrastructure. Key Responsibilities: - Serve as a stand-alone global lead for aggregate reporting, signal management, or literature surveillance projects. - ...

Job Overview Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure. Essential Functions Serve as a stand-alone global lead for aggregate reportin...

Job Overview Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure. Essential Functions Serve as a stand-alone global lead for aggregate reportin...

Role & responsibilities Job Overview : Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions : • 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,...

Job Overview Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables. Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables. Contribute to scientific publi...

Project role : Safety Aggregate Report Manager Work experience : 8+ years. Work location : Bangalore - Homebased. Must have skills : Team Lead, Mentoring Experience Job overview : Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure t...

We are looking for MBBS - Medical Reviewer with 0-3 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 : Sr. Research Scientist / Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 0-3 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 p...

As a Safety Surveillance Adviser at Novo Nordisk, your primary responsibility will be to establish the product safety profile during development and maintenance of the labelling for marketed products. Your role will involve performing ongoing and systematic surveillance of Novo Nordisk products, both pre-approval and post-approval, based on safety information from worldwide sources. You will also be responsible for communicating drug safety issues internally and to health authorities. Additionally, you will be required to establish, operate, and chair the cross-functional safety committee, present analysis and results of ongoing safety surveillance, and make recommendations as necessary. You...

As a Safety Aggregate Report Specialist, you will be responsible for applying your knowledge and expertise in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your essential functions will include: - Serving as the principal owner of the SARA deliverables, ensuring their completion in compliance with all applicable service level agreements (SLA). - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings. - Authoring responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products and assisting...

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead, utilizing your 7+ years of experience in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include: - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory agency inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products, identifying ICSRs, evaluating events, and contributing to literature deliverables for aggregate reports and signal management activities. - Serving as a Signal Management Lead on large post-marke...

As a skilled Live Production Control Room (PCR) Operator, your role will involve managing and monitoring live feeds from the field, performing real-time post-production tasks, and ensuring seamless live streaming to maintain the quality and professionalism of live broadcasts. Your responsibilities will include: - Constantly monitoring live feeds from field correspondents and cameras to ensure high-quality video and audio. - Using professional software to add overlays, tickers, logos, date/time stamps, background scores, and other necessary visual/audio elements to the live feed in real-time. - Applying censorship when necessary by muting audio, blurring visuals, or using placeholders to ensu...

As a Safety Specialist II at our company, your role will involve the following responsibilities: - Authoring and reviewing various Aggregate Safety Reports such as DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required by the project. - Reviewing aggregate safety data, generating line listings (LL) and summary tabulations (ST), and incorporating them into the appropriate templates. - Analyzing safety and regulatory data provided by clients to prepare comprehensive Aggregate Reports. - Conducting literature screening to include significant safety articles in the respective sections of aggregate reports. - Compiling benefit-risk evaluation sections provided by medical reviewe...

Role Overview: As a Director of Safety Risk Management in the Healthcare/Lifesciences industry, you will work on the drug safety (pharmacovigilance) team, focusing on understanding the end-to-end PV lifecycle. Your expertise in ICSRs, Periodic reports, and Signal Management processes will be crucial. Leading and guiding RMP and aRMM processes, along with interacting with stakeholders, will be part of your responsibilities. Defining processes, utilizing swim-lane diagrams, and staying updated with regulatory changes are key aspects of the role. Key Responsibilities: - Discussing gaps and pain points with business users and translating customer needs into solutions for BRM/RMP and aRMM process...

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 protocols (e.g., prot...

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...