52 Signal Detection Jobs

Role & responsibilities Perform signal detection to assess the benefit-risk balance of client product Perform EVDAS database review Collaborate across teams to resolve issues and improve signal methodologies. Support regulatory responses and assist in team training. Escalate urgent signals to Line Manager and QPPV. Ensure ongoing signal monitoring from all safety data sources.

Role Overview: You will be responsible for ensuring the safety and effectiveness of pharmaceuticals through signal detection, risk management, and regulatory compliance. This includes preparing and reviewing Risk Management Plans (RMPs), aggregate reports, and signal detection reports. Your role will also involve training, authoring SOPs/WIs, and ensuring compliance with Good Pharmacovigilance Practices. Key Responsibilities: - Signal Detection and management - Drafting or reviewing signal detection reports - Preparation and review of Risk Management Plans (RMP) - Preparation and review of Risk Management Plan aggregate reports (PADERs/PSURs) - Handling additional Risk Minimization Measures ...

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...

Site Name: Bengaluru Luxor North Tower Posted Date: Oct 21 2025 Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. We're uniting science, technology, and talent to get...

Role Overview: You will be the Global Head of Clinical Development & Patient Safety Solutions at Sandoz, ensuring that Clinical Development & Patient Safety stakeholders achieve their goals using technology systems. Your role involves working closely with stakeholders to understand their evolving needs, challenges, opportunities, and priorities. As a Stakeholder Success Lead, you will represent the face of Technology to the stakeholder community. Key Responsibilities: - Stakeholder Engagement: - Facilitate dialogues to address business issues through technology. - Align technology strategy with business needs. - Manage priorities for Clinical Development & Patient Safety. - Develop and maint...

Role Overview: You will lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Your responsibilities include end-to-end report management, planning, authoring, managing review and submission steps, applying safety domain knowledge, managing deliverables of medium to high complexity, and ensuring timely delivery of high-quality documents to internal customers and sponsors/clients. You will coordinate activities related to several types of report writing across a team of writers, perform support activities such as tracking, maintenance of metrics, quality checks, and training, and assist Medical Writers in preparing safety r...

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...

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. Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER. Authoring of RMP updates & implementation plans. Review of various types of listings for Signal Detection Must have Skill Set Aggregate report Literature review safety signal IC...

As the Global Safety Officer (GSO) for Marketed Products, your primary role is to ensure the safety and well-being of the assigned marketed products. You will be responsible for establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. Your accountability extends to overseeing the overall safety profile, making product-related decisions, and delivering on all associated responsibilities. Key Responsibilities: - Developing and maintaining core reference safety information - Conducting benefit-risk evaluations - Participating in the product label process - Developing strategies for clinical trial safety - Leading responses to safety-...

MBBS Doctor with experience in safety writing and signal detection. ICSR medical review/approval including MedDRA coding, listedness/expectedness,and seriousness assessment. Risk management activities such as drafting, assessment, or implementation of RM activities. Signal management activities such as drafting of qualitative and quantitative signal assessment reports. Clinical practice experience in direct patient care. Aggregate safety report drafting, review or assessment. Must have skill set MedDRA coding Aggregate report signal detection drafting PBRERs Risk Management Plans AE s Contact Person: Maheshwari Balasubramanian Email ID: maheshwari@gojobs.biz

Qualcomm India Private Limited is seeking interns to join the Interim Engineering Intern - HW team. As part of Qualcomm, a company known for unlocking 5G technology and accelerating connectivity, you will be at the forefront of innovation that transforms industries and enriches lives. We are in the Invention Age, and your diverse skills and background are crucial to realizing the potential of 5G in creating world-changing technologies and products. The systems engineering team at Qualcomm has a rich history of conceiving and commercializing wireless communication innovations. From cdma2000 to LTE-Advanced and beyond, we have been at the forefront of technological advancements. We are looking...

In close collaboration with the Global Program Safety Lead (GPSL), you will provide robust safety evaluation expertise and medical innovation to enhance patients" lives and influence Novartis" overall results. As a part of the Medical Safety organization, your priority will be ensuring the safety of patients, optimizing patient safety for assigned compounds, and sharing responsibility for integrating, analyzing, and evaluating internal and external safety information throughout the product lifecycle management. Your main responsibilities will include monitoring the clinical safety of projects/products, conducting medical assessments for cases, identifying safety signals, preparing safety dat...

As the Project Safety Specialist, your primary responsibility will be to manage client or project-specific PSS operations associated with products, including the entire adverse events process. This may involve handling safety data collected from clinical trials and/or post-marketing settings for specified projects. Your role will require you to manage and process expedited adverse events to the required standard and submit them to the client and regulatory agencies within agreed timelines. You will be providing this service to clients either as a support function to client project groups or as a stand-alone business, ensuring the delivery of high-quality service in a safe and cost-effective ...

As a Project Lead, your responsibilities will include leading and managing projects, supervising all project-related activities, and facilitating communication between the Project Manager and the team. You will be tasked with recording, maintaining, and tracking metrics for both team members and project performance. Additionally, you will review and evaluate AE case information to determine required actions based on internal policies and procedures. Your role will also involve processing current incoming cases to meet Regulatory timelines, providing guidance for data entry, following up with sites regarding outstanding queries, and addressing reconciliation discrepancies. It is essential to ...

As a leading global contract research organization (CRO) dedicated to scientific excellence and backed by years of expertise in clinical development, Fortrea offers a diverse array of clinical development, patient access, and technology solutions in over 20 therapeutic areas. Operating in approximately 100 countries, Fortrea is revolutionizing drug and device development worldwide. Your responsibilities will include performing various tasks such as generating reports from databases or safety systems, managing data requests, conducting sales data calculations, and conducting regulatory website searches. You will also have the opportunity to contribute to different safety reports for internati...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc). Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the...

As a Pharmacovigilance/Senior Pharmacovigilance Associate at ICON plc, you will play a crucial role in reviewing and processing safety events, including pre-marketing, post-marketing, medical device, and drug-related information. You will be responsible for conducting safety reviews of clinical and diagnostic data, generating data listings from the safety database, and ensuring the accuracy and quality of the data. Additionally, you will support the development of safety management plans, post-marketing safety activities, and participate in safety-related meetings and teleconferences. Your key responsibilities will include collaborating with cross-functional teams to support safety-related i...

As a Medical Reviewer in the Pharmacovigilance Department, you will be responsible for managing your daily workload under the guidance of the Manager. This includes individual case processing, conducting literature searches, generating aggregate reports, and completing any other tasks relevant to the department. Your role will involve medical review of Individual Case Safety Reports (ICSRs) in the Pharmacovigilance database, as well as preparing aggregate reports for expedited or periodic submissions in compliance with regulations and Standard Operating Procedures (SOPs). You will be expected to ensure compliance with the Company's SOPs and regulatory requirements, and provide support in sig...

Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) according to assigned tasks and project-specific procedures. Analyze abstracts and full articles to extract safety information for both pre and post-marketed products. Generate data listings from the safety database, ensuring data accuracy. Complete adverse event follow-ups via writing and/or phone, tailored to client requirements. Maintain and review relevant safety tracking systems for accuracy and quality, assisting with project file maintenance. Perform safety reviews of clinical and diagnostic data as part of case processing. Develop and maintain the Safety Management Plan, ensuring project cons...

Literature Management Process Review weekly literature results imported into the literature citation management system to determine if they meet minimum criteria for Individual Case Safety Reports (ICSRs) for marketed products Assess literature articles to identify new aggregate safety information relevant to periodic reports or signal detection activities Order full-text articles when additional detail is required to determine reportability or support signal detection Flag relevant articles containing aggregate safety information for secondary review by Therapeutic Area (TA) Safety Coordinate with Local Safety Officers to obtain English translations of non-English articles Notify business p...

Key Responsibilities: Compile and author Periodic Aggregate Safety Reports (PASRs) ensuring accuracy and compliance. Coordinate and schedule meetings with cross-functional stakeholders to ensure effective collaboration and alignment. Drive report timelines, monitor progress, and escalate risks or delays to team leads or management. Collaborate with cross-functional teams and external partners to gather PASR contributions and consolidate into templates. Author safety content in partnership with Therapeutic Area Safety scientists. Conduct peer quality control reviews of authored safety sections, coordinate Amgen internal reviews, resolve comments, and initiate approval workflows. Maintain and ...

Primary Responsibility The primary responsibility of this role is to perform quality control (QC) reviews of Amgen's Periodic Aggregate Safety Reports (PASR), including Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER)/Periodic Safety Update Reports (PSUR), Semi-Annual Safety Update Reports (SSUR), Periodic Adverse Drug Experience Reports (PADER/PAER), Device PSURs, and country-specific reports such as Korea PSUR, Brazil PSUR, and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards, supporting the end-to-end writing and d...

We are seeking a dedicated and detail-oriented PV Specialist to join our team. The associate will work under the guidance of respective Head of Pharmacovigilance of the assigned region and shall be responsible for managing various pharmacovigilance tasks. The ideal candidate will have excellent communication and organizational skills, as well as a strong understanding of regulatory requirements in ROW countries. Responsibilities: Assist in updating both local and core PSMFs Collaborate with partners to create and update SDEAs with the latest consumer healthcare information under the supervision of the Head of Pharmacovigilance of ROW region. Ensure compliance with SDEA requirements, such as ...

PV Physician is primarily responsible for the oversight of and provision of medical input to benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation and review of aggregate reports; signal detection and evaluation; support of benefit-risk evaluation efforts; generation and/or review of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification of risk minimisation measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Me...

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...