27 Signal Detection Jobs

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

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 Sciences, or related field; Master's degree preferred. 3-8 years of experience in pharmacovigilance or drug safety. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proficiency in data analysis and interpretation of safety data. Excellent communication and interpersonal skills. Attention to detail and strong organizational skills.

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 profile PEOPLE LEADER The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. MINIMUM KNOWLEDGE, SKILLS, AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. Education (MBBS/ MD) or comparable education. Experience and/or Training: A minimum of 10 years of drug safety experience. Should have valuable experience in literature review for both Pre-authorization and Post marketing products. Should have valuable experience in reviewing aggregate reports and signal management activities. Technology/Equipment (Microsoft Proficient).

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.

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 submission of safety reports to regulatory authorities. Support risk assessment activities, including signal detection and data analysis. Ensure compliance with international drug safety regulations and guidelines Assist in maintaining pharmacovigilance databases and documentation. Contribute to safety-related documentation such as periodic safety update reports (PSURs). Support the preparation of audits and inspections related to pharmacovigilance activities.