43 Signal Detection Jobs

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 for engineers with a passion for wireless communications and signal processing, individuals who can analyze problems rigorously and guide solutions from the lab to real-world implementation. In this role, you will actively contribute to Qualcomm's systems engineering activities, focusing on the evolution of 3G, 4G, 5G, WLAN, and satellite communications technologies. Your responsibilities will include gaining a deep understanding of physical layer specifications, designing modem baseband algorithms, and contributing to the company's intellectual property portfolio. Skills in PHY and MAC Layers, modem algorithms design, interference management, and network protocols are highly valued. We are looking for candidates with expertise in areas such as information theory, coding theory, digital communications, and familiarity with 3GPP/3GPP2 standards. Proficiency in programming languages like C/C++/MATLAB and familiarity with UNIX/Win/Linux platforms are desired. If you have a background in mobile broadband, IoT, or radio access network design, we encourage you to apply. Qualcomm is an equal opportunity employer committed to providing accessibility during the application and hiring process. For individuals with disabilities requiring accommodations, please reach out to myhr.support@qualcomm.com. Our workplace is designed to be inclusive and supportive for individuals with disabilities. Join Qualcomm in upholding all policies and procedures, including maintaining the confidentiality of company information. As part of our commitment to a secure workplace, we expect our employees to comply with all applicable security requirements. Note to Staffing and Recruiting Agencies: Our Careers Site is exclusively for individuals seeking jobs at Qualcomm. Please refrain from submitting unsolicited profiles, applications, or resumes. Qualcomm does not accept submissions from agencies without prior authorization. For more information about this role, reach out to Qualcomm Careers directly.,

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 data for review boards, and collaborating with various departments for clinical safety tasks. Additionally, you will contribute to developing departmental goals, responding to inquiries from regulatory authorities or healthcare professionals, and providing expert evaluation on adverse event reports. You will be evaluated based on the timeliness and quality of safety analyses, interpretations, and presentations, compliance with internal and external regulations, and the consistency and quality of safety deliverables. To be eligible for this role, you are required to have a Medical Degree (MBBS or MD) with a specialization preferred, along with at least 12 years of experience in drug development in a major pharmaceutical company. Prior experience in patient safety at an operational or medical position is desirable. You should also possess expertise in clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing of publications. At Novartis, we are dedicated to creating a supportive community of passionate individuals like yourself who are committed to making a difference in patients" lives. If you are ready to collaborate, support, and inspire others to achieve breakthroughs in healthcare, we invite you to join our network and contribute to a brighter future together. Novartis is committed to fostering an inclusive work environment and diverse teams that represent the patients and communities we serve. If you require any accommodations due to a medical condition or disability during the recruitment process, please reach out to us at [email protected] with your request and contact information. Join us in our mission to improve lives and make a positive impact on global healthcare.,

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 manner. Compliance with legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 will also be a key aspect of your role. Your responsibilities will include providing leadership and management for global or regional projects, ensuring harmonized communications and processes. You will monitor and manage project workflows to meet deadlines and ensure compliant safety reporting in accordance with international regulations and SOPs. Making decisions regarding adverse event reporting within project guidelines, working closely with clinical operations and project management groups, overseeing the receipt and processing of adverse event reports, and ensuring expedited reporting to regulatory agencies are also part of your duties. Additionally, you will be responsible for managing EudraVigilance activities, performing signal detection, and preparing pharmacovigilance reports, among other tasks. You will contribute to the development and review of various safety-specific plans, prepare and deliver safety presentations, maintain a comprehensive understanding of SOPs and guidance documents related to safety management, and provide support and training to team members. Building and maintaining good drug safety relationships, demonstrating role-specific competencies and company values, and handling financial authority related to projects will also be part of your role. To qualify for this position, you should have a minimum of 8 to 12 years of non-degree experience, preferably in disciplines such as Biological Sciences, Pharmacy, Nursing, Life Sciences, or Chemistry. Safety experience, knowledge of pharmacovigilance regulations, Good Clinical Practice, ICH guidelines, and medical and drug terminology are essential. Strong leadership, communication, and problem-solving skills, as well as the ability to work collaboratively and handle project management, are required. Preferred qualifications include EudraVigilance Certification and knowledge of Medical Device Reporting. The physical demands of this role involve working in an office environment with occasional travel required (10-15% of the time) including overnight stays as necessary. Your role will be crucial in ensuring the efficient and compliant management of safety processes and reporting for assigned projects, contributing to the overall success of the organization.,

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 adhere to departmental AE workflow procedures and train and mentor new team members as per project requirements. Moreover, you will be expected to author/draft aggregate reports and quality reviews such as PBRER, PSURs, PADER, Addendum to Clinical Overviews, RMP, and Signal detection reports. The ideal candidate should have 7-10 years of relevant experience and hold a qualification of MBBS/MD/M.Pharm. This position is based in Hyderabad.,

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 international regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and other related documents. Your role will involve developing report sections, reviewing line listings, preparing case narratives, and participating in comment resolution discussions. Additionally, you will support medical writers in signal detection activities by assisting with data cleaning, reviewing line listings, and creating materials for signal review meetings. Fortrea is actively looking for individuals who are motivated problem-solvers and innovative thinkers eager to tackle challenges in clinical trials. Our primary goal is to transform the development process and facilitate the rapid delivery of groundbreaking ideas and treatments to patients in need. By joining our exceptional team, you will be part of a collaborative environment that fosters personal growth and enables you to contribute to a significant global impact. Fortrea is an equal opportunity employer that values diversity and inclusion in the workplace. To learn more about Fortrea and our commitment to excellence, please visit www.fortrea.com. For information regarding the collection and storage of personal data, please refer to our Privacy Statement. If you require a reasonable accommodation during the job application process, pre-employment testing, or job interview, or need assistance to participate in the hiring process, please contact taaccommodationsrequest@fortrea.com. Kindly note that this email address is exclusively for job seekers requesting accommodations and should not be used to inquire about application status.,

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 risk-benefit balance. SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training. Development of customer-specific solutions and processes in cooperation with clients. Build, develop and maintain working relationships with clients. Ensure client satisfaction and compliance with legal and regulatory requirements. Representation of the company and the team with clients, authorities and professional institutions. Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. Management of parts of a project or the complete project. Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance. Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date. Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies. Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department. Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates. Contribute to achievement of departmental goals, Identify and discuss out-of-scope activities that affect project invoicing. Client audits (preparation of the audit, defend it, review the audit report and follow action plan). Contribute to resource needs and resource allocation to ensure compliance, identification and implementation of process efficiency needs. Minimum 4 years of experience in relevant field. Experience in writing and reviewing PBRER, PSUR, RMP, PADER and ACO Experience in Preparation of responses to PRAC, other authority requests Experience in writing and review SOP, preparing training material Build update and maintain working relationships with client What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Show more Show less

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 inquiries, conducting signal detection and risk assessment activities, and ensuring timely and accurate reporting of adverse events in compliance with regulatory guidelines. You will also assist in the preparation of safety reports and regulatory submissions, staying up-to-date with pharmacovigilance regulations and industry best practices. To qualify for this role, you should hold a Bachelor's degree in life sciences, pharmacy, or a related field, with an advanced degree being preferred. Previous experience in pharmacovigilance, drug safety, or a related area within a clinical or pharmaceutical environment is desirable. Strong analytical skills, attention to detail, excellent communication, and interpersonal skills are essential for effective collaboration with team members and stakeholders. You should demonstrate a commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. At ICON, we value our people and aim to create a diverse culture that fosters talent and rewards high performance. In addition to a competitive salary, we offer a range of benefits designed to promote well-being and work-life balance for you and your family. These benefits include various annual leave entitlements, health insurance offerings, retirement planning options, and a Global Employee Assistance Programme. If you require a reasonable accommodation due to a medical condition or disability during the application process, please inform us. Even if you are unsure whether you meet all the requirements for the role, we encourage you to apply as you may be exactly what we are looking for at ICON. Visit our careers site to learn more about the benefits we offer and explore exciting opportunities to shape the future of clinical development with us.,

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 signal detection of Adverse Drug Reactions (ADRs) for client products. Additionally, you may be involved in the medical review of Periodic Safety Update Reports (PSUR) and handling medical queries or spontaneous ADR cases as per applicable SOPs. Training and mentoring new medical reviewers in Pharmacovigilance may also be part of your responsibilities. Staying up-to-date with changes in regulations affecting pharmacovigilance activities and communicating these updates to relevant stakeholders is essential. You will be involved in the generation and execution of company SOPs and Work Instructions, and maintaining strong relationships with clients and internal/external contacts. Administrative duties, liaising with international offices and clients, and collaborating with cross-functional teams are also key aspects of this role. Your dedication to maintaining good relationships, following ISMS-related procedures and policies, and performing any other duties assigned by management will contribute to the overall success of the Pharmacovigilance Department. This is a full-time position that requires a Bachelor's degree. Kindly confirm if you hold an MBBS/MD qualification. Please note that the work location is in person, and you should be prepared to work collaboratively with team members to achieve required outcomes and meet timelines.,

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 consistency. Support post-marketing safety activities, including PSMF, RMP, and PBRER. Liaise with investigational sites, reporters, and sponsors regarding safety issues. Collaborate with ICON Medical Monitor, project managers, and other departments as needed. Assist in identifying out-of-scope activities in collaboration with the Pharmacovigilance Project Lead. Attend project team and Sponsor meetings, presenting safety processes as required. Support the generation of aggregated safety reports, including Development Safety Update Reports and Periodic Safety Update Reports. Maintain the safety database and ensure quality control of data entry. Aid in the creation and reconciliation of SAE/AE plans. Support signal detection and risk management activities. Propose solutions for procedural and technical challenges. Assist with audits and inspections as needed for assigned projects. Respond to and process medical inquiries related to adverse events and product complaints. Your Profile: Experience in a pharmaceutical or CRO environment. At least 1 year of experience in pharmacovigilance. Excellent verbal and written communication skills. Detail-oriented with strong organizational and time management abilities. Fluent in written and verbal English. Ability to work effectively both independently and as part of a team across global teams

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 partners upon receipt of relevant literature articles, if applicable Conduct retrospective quality checks of literature reviews performed by the team Support audit and inspection readiness Collaborate with Case Management and TA Safety for continuous process improvements Propose proactive system or process enhancement ideas Periodic Reporting Process Assist with quality control activities related to periodic safety reporting, as needed Extract citations from literature databases for inclusion in periodic aggregate safety reports Key Activities Execute weekly literature reviews in support of global literature surveillance Support audits and inspections by retrieving citations from the literature management system Assist with quality control tasks to ensure high standards in periodic reporting Knowledge and Skills Familiarity with assigned product profiles to assess reportability of literature content Ability to identify articles with ICSR criteria or containing safety signals for escalation Proficient in full-text article retrieval and ordering procedures Open to feedback from TA Safety and Case Management and able to adjust review practices accordingly Demonstrated understanding of global pharmacovigilance regulations and surveillance standards Strong prioritization skills and ability to manage concurrent timelines Expertise in literature citation management systems and configuring literature search strategies Exposure to AI tools and prompts is considered an advantage Contribution Ensures Amgen's continued compliance with global regulatory requirements through high-quality literature reviews Responsible for timely completion of weekly literature screening to support global safety processes Education & Experience (Basic) 59 years of experience in pharmaceutical, biotech, or regulatory authority settings, ideally within R&D Direct experience in bibliographic databases and literature review is preferred

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 archive accurate documentation throughout the report lifecycle. Review and approve final published report versions (including blinded, unblinded, EU FDA, Rest of World versions). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs). Ensure adherence to regulatory guidelines, company standards, timelines, and style guidelines. Perform peer and quality reviews of all PASRs within timelines using established checklists and processes. Maintain and update knowledge of regulatory guidelines, technological advancements, and industry best practices. Generate and report PASR metrics including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Assist with Literature Management activities as needed. Basic Qualifications and Experience: Master's degree or Bachelor's degree with 5 years of relevant experience.

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 documentation process while ensuring timelines are met. Key Responsibilities Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure accuracy of content, data integrity, formatting consistency, and adherence to regulatory and internal standards. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate closely with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry best practices for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and Standard Operating Procedures (SOPs) to standardize and improve review practices. Track QC metrics and support continuous improvement initiatives related to the quality and timely delivery of safety reports. Basic Qualifications and Experience Total experience: 5-9 years in relevant roles At least 2-3 years of experience specifically in Quality Control (QC) Bachelor's or Master's degree in Life Sciences, Pharmacy, or related field

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 reconciliation of PV activities in ROW region. Keep activity tracking spreadsheets up-to-date to ensure all tasks are consistently monitored and recorded. Manage the Eudravigilance database and perform signal detection activities as required. Manage RMP queries and CMDh risk notifications. Update RMPs post-authorization and track related variations with RA. Ensure compliance for aggregate reports, including PSUSAs, for regulatory intelligence and tracking tasks to be addressed in the next PSUR, as well as establishing a close monitoring list. Manage deviations and CAPAs: Identify and report any deviations in procedures and participate in CAPA development, assuming responsibility for CAPA completion when assigned. Provide support during audit and inspection preparation, actively participate during audits, address any observations, and assist in CAPA closure Able to manage any assigned task of Pharmacovigilance on ad-hoc basis. Relationship Management Working with other regional teams and central cross functional teams across the Globe. Interactions with vendor's/service providers for PV activities. Process Improvement / Standardization Participate in process improvement initiatives under supervision of Head of Pharmacovigilance of respective region. Qualifications Desired Skills & Competencies Bachelor's degree in pharmacy, Master's degree is preferred. Minimum 8 years of experience in pharmacovigilance out of which at least 3 years in core pharmaceutical company. Strong understanding of regulatory requirements and guidelines of respective countries Excellent communication and organizational skills Proficiency in Microsoft Office, including Excel, PowerPoint Ability to work independently and as part of a team. Detail-oriented and able to manage multiple tasks simultaneously.

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, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities. Main Responsibilities: Medical Review quality control of medical assessment of individual case safety reports (including coding, seriousness, expectedness, and company causality assessments) done by the vendor. Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar. Provide medical input and/or review of Medical Assessment deliverables including but not limited to aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs and ACOs. Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor. Support the PV Scientists in ensuring all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements. Provide medical input to signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. Signal evaluation: Validation of potential signals and ensure appropriate actions are taken for confirmed signals. Summarize findings and present to the Head of Medical Assessment, Regional PV Heads and Glboal Head of Global Pharmacovigilance at appropriate forums such as signal management committee. Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations. Provide medical input to RMPs/REMS and aRMMsas required and review RMPs authored by PV Scientists. Prepare and/or review Health Hazard Evaluations and other ad hoc safety reports as requested. Contribute to the identification and design of additional risk minimization measures and support their implementation in collaboration with PV Scientists, local affiliates and third-party partners. Clinical & Regulatory Activities: Provide medical/safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review, final study reports, dossier documents and other documents required to support filing activities.Participation in product/project team meetings. Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required. Labeling document review: provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information. Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV-related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure. Participate in due diligence activities for product acquisitions/divestments as required. Participate in development of CAPA and take ownership of CAPA completion where assigned. Participate in regular, scheduled meetings with PV team/service provider/third parties as required. Support for PV QMS: Support the development and revision of department SOPs and work instructions. And participate in the review of cross-functional SOPs which include reference to PV activities. Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training. Act as SME for above activities during audit and regulatory authority inspections, as needed. Any other activity assigned by Head Medical Assessment. Relationship Management Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units. Interactions with vendors/service providers for PV activities. Process Improvement / Standardization Participate in process improvement initiatives under supervision of Head of Medical Assessment and Global Head of Pharmacovigilance to promote internal audit and regulatory inspection readiness. Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing. Qualifications Education: MBBS preferably with MD At least 5 years of relevant PV experience after MBBS Desired Skills & Competencies Good working knowledge of PV regulations including FDA, EU & local requirements. Strong data analysis and report writing skills. Excellent teamwork and interpersonal skills. Strong problem solving and decision-making skills.

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-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

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 defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system in terms of medical review of safety cases and management of safety signals. Key Responsibilities: - Conduct medical review of ICSRs, including assessment of Literature cases and authoring of enhanced MAC. - Support safety lead in authoring medical assessment letters based on the bi-annual/six-monthly line listing. - Perform literature review of assigned articles and assist in the review of articles for inclusion in PBRER, DSUR, IB, etc. - Provide support to Therapeutic Areas as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents. - Assist in monitoring the safety profile of products, including activities such as literature review, medical review of individual cases, and medical evaluation of quality defects. - Co-author the PBRER and provide medical inputs to specific sections, including follow-up activities on HA assessment reports. - Contribute to the medical sections of DSUR, IB, labeling documents, Product Guidance Documents, and Expert Statements. - Support signal detection and evaluation activities for assigned products. - Assist in the preparation of Health Authority queries and other safety-related documents. - Act as a Subject Matter Expert for Medical Function processes and provide support during audits and inspections. - Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities. - Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality. - Assist in the development and optimization of training materials and deliver training to Novartis staff and external stakeholders. Minimum Requirements: - Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in relevant field, or Medical Degree (MBBS or MD) required. - Minimum 3 years of experience in the pharmaceutical industry or related field. - Experience in safety document or medical writing, including proficiency in coding with MedDRA and WHO dictionaries. - Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology. - Attention to detail and quality focus. - Strong organizational and project management skills. - Excellent communication skills and ability to operate effectively in an international environment. - Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. - Technical understanding of Biomedical/Biostatistics concepts and strong problem-solving skills. - Good presentation skills. - Proficiency in computer skills, including creating spreadsheets, templates, presentations, and working with safety databases/applications. - Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.,

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. Additionally, familiarity with project management tools like Jira and Confluence is necessary to collaborate effectively with cross-functional teams. An advanced knowledge of R, HTML, and GitHub will further support your role in this dynamic environment.,

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 detection, medical writing, and safety database compliance. * Strong knowledge of GVP regulations, safety audits, and variation submissions. Interested? Apply Now or Share Your CV at: swati.dussa@peoplesense.in or 9321287591

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 to regulatory authority inquiries regarding safety issues Qualifications MBBS / MD (Pharmacology, Internal Medicine, or equivalent) Mandatory Minimum 2-5 years of experience in pharmacovigilance or clinical safety Prior experience in medical review of PV cases and signal management preferred Familiarity with ICH-GCP , MedDRA , WHO-ART , and global regulatory guidelines Experience with Argus / ARISg or other PV databases is a plus Excellent written and verbal communication skills Interested to apply can share CV or call/WhatsApp to 9342735755

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 compliance expertise to GPS as required. Your responsibilities as a Global PV Sr. Scientist include directing the planning, preparation, writing, and review of portions of aggregate reports. You will also coordinate liaison activities with affiliates and other internal partners at Amgen regarding products. Furthermore, you will provide oversight to staff on safety in clinical trials, review study protocols, statistical analysis plans, clinical study-related documents, adverse events, and safety data from clinical studies. You will be involved in signal detection, evaluation, and management, performing data analysis for safety signals, documenting work in the safety information management system, authoring Safety Assessment Reports, and collaborating with the GSO on safety documents and regulatory responses. Additionally, you will support risk management activities, prepare responses to regulatory inquiries, and contribute to new drug applications and other regulatory filings. In terms of inspection readiness, you will undertake activities delegated by the QPPV as outlined in the PV System Master File and maintain a state of inspection readiness. You will also serve as a representative and point of contact for Health Authority Inspections and Internal Process Audits within your role and responsibility. Your knowledge and skills should encompass a range of areas including pharmacovigilance regulations, drug development, safety data capture, safety database structure, MedDRA, safety data analysis, risk management, and product knowledge. You should also possess intermediate skills in various pharmacovigilance processes, document writing, risk management plans, statistical methods, biomedical literature review, organization, collaboration, critical assessment, scientific writing, and communication. A strong background in pharmacovigilance, expertise in defined subject areas, problem-solving abilities, autonomy in executing strategies, and a contribution to business results through quality and leadership are essential. Your education should include a Doctorate/Masters degree/Bachelors degree with 12 to 17 years of directly related experience, preferably in Life Sciences with managerial experience and clinical/medical research expertise in a biotech/pharmaceutical/CRO setting.,

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 Evidence Generation Team, you will contribute to the evidence generation process. When necessary, you may act as a delegate for the TAH and manage Global Safety Scientists. Your key activities will involve various tasks depending on the assigned product(s). These activities include but are not limited to: - 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 from regulatory agencies - Performing signal detection activities - Evaluating safety signals and determining further analysis strategies - Developing risk management plans - Ensuring timely preparation of periodic safety reports - Participating in safety governance meetings - Representing Global Patient Safety in commercialization processes - Undertaking activities for inspection readiness - Participating in safety agreement development and review process - Interacting with external stakeholders on safety-related topics - Providing safety input to support legal needs - Overseeing day-to-day activities of the Global Safety Physician (if applicable) - Providing training, coaching, mentoring, and development of staff - Assisting in the recruitment of talented personnel - Disseminating and representing corporate and departmental information to staff The ideal candidate for this position should hold a Medical Degree (MBBS or MD) from an accredited medical school and have a minimum of 8 years of relevant experience in product safety within the bio/pharmaceutical industry, CRO, or regulatory agency. Previous management and/or mentoring experience, as well as clinical/medical research experience, are preferred qualifications.,

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 compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55