99 Aggregate Reporting Jobs

Position: Sr. Research Scientist MSSRM Department: Global Vigilance Centre – Gurgaon Location: Gurgaon (Work From Office mandatory; 1-day flexi working option available) Qualification Requirements MBBS/MD with 0–3 years of experience in pharmacovigilance. Mandatory: Expertise in medical review of aggregate reports (PSURs/PBRERs). Preferred: Experience in medical review of signal management and ICSRs. Key Responsibilities Design, develop, and maintain procedures for medical review activities, including ICSR, aggregate reports, and signal management. Ensure high-quality deliverables across ICSR, aggregate, and signal management outputs. Perform medical review of ICSRs, aggregate reports (PSURs...

Role & responsibilities The role requires the individual to support Safety Signal Management by processing of signals of disproportionate reporting and by collation and review of signal evaluation reports. Supporting aggregate reports by medical review of individual case safety reports for assigned periodic reports for various regions around the globe. Details of the responsibilities: 1. Signal Management: a. Processing and Evaluation • Processing of Signals of Disproportionate Reporting (SDRs) Causality assessment of unexpected case occurrences/ SDRs b. Report Generation Drafting of molecule specific Signal Evaluation Reports Drafting of molecule specific Signal Inputs for ADCOs / PBRERs/ P...

Location: Kodambakkam / Gummidipoondi Department: Pharmacovigilance Position: Pharmacovigilance (PV) Associate Job Type: Full-time Role Overview : The Pharmacovigilance (PV) Associate is responsible for the timely and accurate processing of adverse event reports, ensuring compliance with global and local regulatory requirements for drug safety. Key Job Responsibilities 1. Case Management & Processing Receive and Triage: Intake and prioritize all incoming adverse event (AE) reports from various sources (e.g., spontaneous reports, literature, clinical trials, and regulatory authorities). Data Entry: Perform detailed and accurate data entry of AE reports ensuring complete case documentation. Ca...

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,...

Job Description: Provide medical review, analysis, and guidance during the case handling and reporting cycle of Individual Case Safety Reports and ADR reports for investigational and marketed products. Conduct detailed ICSR Medical Review to assess causality, seriousness, and completeness, ensuring compliance with regulatory requirements. Writing of safety sections, including benefit-risk assessment of Aggregate Reports such as PSURs, CASRs, and PADERs. Provide guidance to Drug Safety Associates on the medical aspects of drug safety, including case-by-case assessments and aggregate analysis. Analyze ADRs during ongoing surveillance and signal detection, including independent analysis of safe...

Key Responsibilities: Approve and schedule reports in the Argus database for submission to respective Health Authorities, as applicable. Submit cases to Health Authorities, Business Partners, and Affiliates as required. Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance. Schedule and approve regulatory reports based on reporting obligations. Job Requirements: Years of Experience: 4 to 6 years of relevant experience in Pharmacovigilance (PV), specifically in ICSR Quality Review and Regulatory Report Submissions. Hands-on experience with the Argus Database is essential. Educational Qualification: B.Pharmacy / M.Pharmacy Skills an...

Key Responsibilities: Authoring and Reviewing PSURs and RMPs Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs) for submission to health authorities. Ensure the accuracy, completeness, and regulatory compliance of all PSURs and RMPs. Literature Search and Validation Perform literature searches to gather relevant data for PSUR and RMP preparation. Validate the information obtained from literature searches to ensure accuracy. Data Management Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). Generate Line Listings (LL) from the safety database...

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...

Key Responsibilities: Authoring and Reviewing PSURs and RMPs Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs) for submission to health authorities. Ensure the accuracy, completeness, and regulatory compliance of all PSURs and RMPs. Literature Search and Validation Perform literature searches to gather relevant data for PSUR and RMP preparation. Validate the information obtained from literature searches to ensure accuracy. Data Management Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). Generate Line Listings (LL) from the safety database...

Job Description: Provide medical review, analysis, and guidance during the case handling and reporting cycle of Individual Case Safety Reports and ADR reports for investigational and marketed products. Conduct detailed ICSR Medical Review to assess causality, seriousness, and completeness, ensuring compliance with regulatory requirements. Writing of safety sections, including benefit-risk assessment of Aggregate Reports such as PSURs, CASRs, and PADERs. Provide guidance to Drug Safety Associates on the medical aspects of drug safety, including case-by-case assessments and aggregate analysis. Analyze ADRs during ongoing surveillance and signal detection, including independent analysis of safe...

Job Role : Pharmacovigilance (Aggregate Reporting) Designation : Assistant Manager Job Description: Preparation and review of aggregate reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc. Co-ordination with various stakeholders to gather data required for Aggregate reports. Work closely with service providers and resolve their queries. Co-ordinate with various stakeholders internal and external required for the completion reports. Preparation and review of Query responses from Regulatory Authority Job Specification : B. Pharm/ M. Pharm with 6-12years of ex...

Job Description Responsible for medical review of safety reports, triage activities and signal management activities Perform signal detection, signal validation, prioritization and signal assessment and propose recommendation. Perform safety evaluation of ongoing signals, safety issues, IRSR, etc. Review of non-ICSR scientific literatures from signal and aggregate report perspective. Provide safety concerns, search criteria and literature review for aggregate reports. Perform medical evaluation of aggregate reports (PSUR, PBRER, PADER, ASR etc.,) and analyze benefit-risk balance of the product. Provide medical support to the safety writing team. Review of Risk Management Plan and risk mitiga...

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.

We are looking for MBBS - Medical Reviewer with 0-3 years of experience in Pharmacovigilance having expertise in review f aggregate reports. Candidate who are willing to come to office and work from office only can apply. Designation : Sr. Research Scientist / Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 0-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended). Location : Gurgaon (Work from office is must with one-day flexi working option) Job Responsibility Design, develop and maintain p...

Develop and implement effective aggregate reporting strategies to meet business objectives.Analyze complex data sets to identify trends,patterns, providing insights to stakeholders.Create comprehensive reports using various tools and technologies Required Candidate profile Minimum 2 years of experience in aggregate reporting or a related field.Strong understanding of employment firms and recruitment services.Excellent analytical and problem-solving skills.

Develop high-quality aggregate reports related to pharmacovigilance. Conduct thorough research and analysis to identify trends and patterns in medical data. Collaborate with cross-functional teams to ensure timely delivery of reports. Required Candidate profile Minimum 2 years of experience in medical writing, preferably in pharmacovigilance or aggregate reporting. Strong knowledge of pharmacovigilance principles and regulations.

Develop high-quality aggregate reports related to pharmacovigilance. Conduct thorough research and analysis to identify trends and patterns in medical data. Required Candidate profile Minimum 2 years of experience in medical writing, preferably in pharmacovigilance. Strong knowledge of aggregate reporting principles and practices.

Develop high-quality aggregate reports on medical data, including patient safety and efficacy. Conduct thorough analysis of medical records to identify trends and patterns. Required Candidate profile Minimum 2 years of experience in medical writing, preferably in Pharmacovigilance. Strong knowledge of medical terminology, anatomy, and physiology.

Develop and implement effective aggregate reporting strategies to meet business objectives. Analyze complex data sets to identify trends and patterns, providing insights to stakeholders. Required Candidate profile Minimum 2 years of experience in aggregate reporting or a related field. Strong understanding of employment firms and recruitment services. Excellent analytical and problem-solving skills.

Develop high-quality aggregate reports on medical data, including patient safety and efficacy.Conduct thorough analysis of medical records to identify trends and patterns.Collaborate with cross-functional teams to ensure accurate Required Candidate profile Minimum 2 years of experience in medical writing, preferably in Pharmacovigilance. Strong knowledge of medical terminology, regulations, and industry standards. Excellent writing, communication,

Aggregate Report Specialist JOB DESCRIPTION Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Aggregate Report Specialist Location: Bengaluru/Mysore - Hybrid Function: Drug Safety DESCRIPTIO...

Role & responsibilities: Responsible for coordinating Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR writing medical review, handling of requests received from Central Local Regulatory Affairs and PV departments) within respect of timelines and any other related task. Responsible for coordinating Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department) within timely manner. Responsible for Signal Management related activity (including signal detection ...

Job Description Drug Safety Physician At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commerc...

What you will do The Global HEOR Systematic Literature Review (SLR) Leader oversees the development and delivery of systematic literature review activities within Amgens Global HEOR function. This operational and managerial role includes supervision of a team of Global HEOR SLR Analysts, ensuring high-quality, timely, and scientifically robust literature review outputs. The Global HEOR SLR Leader will align closely with Global HEOR TA Heads in support of global market access and value demonstration for Amgens products across their lifecycle. Lead, mentor, and handle a team of Global HEOR SLR Analysts, fostering a high-performance culture. Oversee the design, execution, and quality control of...

Develop and implement aggregate reporting solutions to meet business requirements. Collaborate with cross-functional teams to identify and prioritize reporting needs. Design and maintain complex reports using various reporting tools and technologies. Analyze data to identify trends and patterns, providing insights to stakeholders. Ensure data accuracy and integrity in all reports and dashboards. Provide training and support to end-users on reporting tools and technologies. Job Requirements Strong understanding of aggregate reporting principles and methodologies. Proficiency in designing and developing complex reports using various reporting tools and technologies. Excellent analytical and pr...