54 Signal Detection Jobs - Page 2

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...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...

We are looking for a detail-oriented Fresher Pharmacovigilance Associate to join our pharmacovigilance team. In this role, you will assist in monitoring and reporting adverse drug reactions (ADRs), contributing to risk assessment processes, and ensuring compliance with global drug safety regulations. This is an exciting opportunity for someone eager to begin their career in the pharmaceutical industry. Monitor and report adverse drug reactions, assist in risk assessment and ensure compliance with global drug safety regulations. Key Responsibilities: Monitor and collect reports of adverse drug reactions (ADRs) from clinical trials and post-marketing sources. Assist in the preparation and subm...