66 Signal Detection Jobs

As a member of the team at Cencora, you play a crucial role in contributing towards creating healthier futures. Your responsibilities will include: - Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases, and signal detection. - Writing various safety reports such as Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), Clinical Expert Statements, etc. - Publishing, distributing, archiving, and submitting safety reports. - Preparing Signal detection reports, including EVDAS scre...

In this role, you will be responsible for performing case intake of Individual Case Safety Reports (ICSRs) from various sources such as patients, healthcare professionals, and literature. Your key responsibilities will include entering and updating safety data accurately in pharmacovigilance databases, conducting initial assessment and triage of reported adverse events, and assisting in coding medical terms using MedDRA. Additionally, you will ensure timely and compliant reporting of safety cases to regulatory authorities and support the preparation of safety narratives and case summaries under supervision. You will also review source documents for accuracy and completeness, assist with sign...

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,...

As the Global Safety Officer (GSO) for Marketed Products, you play a crucial role in ensuring the safety and well-being of the assigned marketed products. Your responsibilities include establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. You are also accountable for overseeing the overall safety profile, making product-related decisions, and delivering on all associated 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-related inquiries...

Job Description: We are a leading provider of pharmacovigilance analytics software for the pharmaceutical industry, delivering innovative, data-driven solutions that help clients enhance drug safety, regulatory compliance, and operational efficiency. As a Programme Manager, you will be responsible for the successful orchestration of interrelated projects that together deliver significant business value to both clients and the organisation. You will provide strategic oversight, ensure alignment with organizational objectives, and lead senior project managers and cross-functional teams to deliver program outcomes on time, within budget, and to high quality standards. This role is ideal for a h...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Site Name: GSK HQ, India - West Bengal - Alipurduar, Warsaw Posted Date: Nov 25 2025 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 ...

Site Name: GSK HQ, India - West Bengal - Alipurduar, Warsaw Posted Date: Nov 25 2025 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 ...

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and dev...

Role Overview: As a Senior Global Patient Safety Leader-Team Lead at Novartis, you will serve as a strategic leader within the Medical Safety organization, aiming to enhance patient lives and contribute positively to Novartis" overall results through effective safety risk management. Your role will involve predicting safety risks, assessing scientific information, and guiding assigned teams on strategic considerations and risk management in development programs. You will be responsible for ensuring optimal patient safety for assigned compounds by integrating, analyzing, and interpreting internal and external safety information throughout the lifecycle management. Key Responsibilities: - Mana...

As an Interim Engineering Intern - HW at Qualcomm India Private Limited, you will be part of a team that has been at the forefront of conceiving and commercializing key innovations in wireless communication systems over the past thirty years. Your role will involve actively participating and contributing to Qualcomm's systems engineering activities related to the evolution of 3G, 4G, 5G, WLAN, and satellite communications technologies towards ever-improving efficiency and capability. Your responsibilities will include gaining a thorough understanding of 3GPP/3GPP2 physical layer specifications, designing WWAN modem baseband algorithms, performance characterization, fixed-point design, and va...

Role Overview: At GSK, you will be providing medical and scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting. Your role involves ensuring scientifically sound review and interpretation of data, managing safety issues, and escalating safety issues as necessary. You will focus on efficiency and effectiveness to meet the needs of patients and healthcare providers, supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets. Key Responsibilities: - Responsible for signal detection and evaluation activities for assigned products. - Produce accurate and fit-for-pu...

As an Interim Engineering Intern - HW at Qualcomm India Private Limited, you will be part of a team of inventive minds that have unlocked 5G and are constantly working on transforming industries and enriching lives in the Invention Age. **Role Overview:** You will actively participate and contribute to Qualcomm's systems engineering activities related to the evolution of wireless communication technologies like 3G, 4G, 5G, WLAN, and satellite communications. Your responsibilities will include gaining a thorough understanding of 3GPP/3GPP2 physical layer specifications, designing WWAN modem baseband algorithms, theoretical analysis, computer-aided analysis, and contributing to Qualcomm's IP p...

Please find the job description for the Pharmacovigilance role below. **Role Objective:** This role is responsible for ensuring the safety and effectiveness of pharmaceutical products. Key activities include signal detection, risk management, and maintaining regulatory compliance. This involves preparing and reviewing Risk Management Plans (RMPs), aggregate reports, and signal detection reports. The role also includes training team members, authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs), and ensuring adherence to Good Pharmacovigilance Practices. **Key Responsibilities:** * Signal detection and management, including drafting and reviewing signal detection reports....

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...