66 Signal Detection Jobs - Page 2

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...

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

As a Statistical Modeller - Clinical, you will be responsible for utilizing your expertise in clinical trials and clinical data monitoring to develop and implement statistical models. Your role will involve working with Bayesian and Frequentist models, as well as handling EDC, CTMS, ePro, and eCOA systems. You will also be involved in RBQM, signal detection, KRI analysis, and outlier detection. In this position, a strong understanding of GCP ICH E6/8 and EMA Guidelines is essential. Proficiency in statistical software such as SAS, R, JMP Clinical, and Python will be required for data analysis and modelling. Experience with visualization tools like Tableau and Power BI will also be beneficial...

Were Hiring: Specialist Patient Safety Are you a passionate life sciences professional with expertise in Pharmacovigilance and Patient Safety? Location: Mumbai Key Responsibilities: * Draft and review PSURs, PBRER, PADERs, and signal reports (DSR, DEP, SAR). * Author ad hoc safety documents (RMPs, CES, HA responses). * Contribute to ongoing improvement of PV systems & compliance. * Support clinical evaluations and regulatory inspections. * Monitor global PV requirements (Europe & RoW). * Collaborate with cross-functional teams and represent the company at scientific meetings. Qualifications: * MBBS Skills & Experience: * 2+ years in Pharmacovigilance / Drug Safety * Experience with signal de...

Roles and Responsibilities Perform medical review of Individual Case Safety Reports (ICSRs) , Serious Adverse Events (SAEs), and SUSARs Conduct causality and seriousness assessments of adverse events Validate case narratives and ensure medical accuracy and regulatory compliance Participate in safety signal detection and risk evaluation Contribute to the preparation and review of aggregate reports : PSUR, PBRER, DSUR, RMP Support updates to product safety labels (SmPC, PI) based on current safety data Collaborate with regulatory, clinical, and medical affairs teams for cross-functional safety activities Provide clinical input on global pharmacovigilance strategies and safety documents Respond...

The Global Safety Therapeutic Areas at Amgen serve as the safety experts for all Amgen products globally. They are responsible for defining the safety strategy and major safety deliverables for each Amgen product. As a leader in the therapeutic area safety teams, you will oversee staff management and resource allocations in Global Patient Safety. Your role will involve supporting GPS in establishing a highly effective global safety organization that complies with worldwide regulations. As a Global PV Sr. Scientist, you will collaborate with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Additionally, you will provide scientific and ...

The Global Safety Officer (GSO) for Marketed Products plays a crucial role in ensuring the safety and well-being of the assigned marketed products. As a GSO, 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. Leading the Safety Analysis Team (SAT), Global Safety Team (GST), and serving as a core member of the Executive Safety Committee (ESC), you will be an integral part of the safety governance structure. Additionally, as a member of the Eviden...

Diensten Tech Limited is looking for Medical Safety Physician to join our dynamic team and embark on a rewarding career journey Review adverse event reports and ensure compliance with medical safety regulations Assess drug safety profiles and provide recommendations for risk management Collaborate with regulatory authorities and medical teams for patient safety Analyze clinical data to improve pharmacovigilance and adverse event reporting

Diensten Tech Limited is looking for Senior PV Specialist to join our dynamic team and embark on a rewarding career journey Monitor and assess the safety of pharmaceutical products Conduct pharmacovigilance activities and report adverse drug reactions Ensure regulatory compliance in reporting safety data Collaborate with healthcare professionals and research team

Hi, We are hiring for Leading ITES Company for Aggregate Report Writer Profile. Please Apply, We shall call back relevant profiles. Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform comp...

We are seeking a dedicated and detail-oriented Executive in Pharmacovigilance to join our team in India. The ideal candidate will have experience in monitoring drug safety and ensuring compliance with regulatory requirements. Responsibilities Monitor and evaluate adverse drug reactions and safety data from various sources. Prepare and submit periodic safety reports to regulatory authorities. Collaborate with cross-functional teams to ensure compliance with pharmacovigilance regulations. Conduct signal detection and risk management activities. Maintain up-to-date knowledge of pharmacovigilance guidelines and best practices. Skills and Qualifications Bachelor's degree in Pharmacy, Life Science...

CLINIMINDS IS RECRUITING THIS POSITON FOR THE THE US BASED GLOBAL PHARMA CONSULTING AND PHARMACOVIGILANCE FIRM Role & responsibilities The Associate Director will lead the medical evaluation of Individual Case Safety Reports (ICSRs), oversee the clinical review of aggregate safety reports (e.g., PBRERs, DSURs, ACOs), and provide strategic and medical input in signal detection and benefit-risk assessments for the companys product portfolio, including biosimilars. The role ensures compliance with global regulatory requirements and drives excellence in pharmacovigilance science. ICSR Medical Review Aggregate Report Review Signal Management Cross-functional Collaboration Preferred candidate prof...