87 Aggregate Reporting Jobs - Page 2

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case clos...

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations In...

As a Senior/Lead Medical Reviewer with 1 3+ years of experience in Aggregate Reporting, Signal Management, or RMP, you will play a crucial role in our team. Your responsibilities will include overseeing the implementation of operational tasks in safety writing, monitoring service performance, and mentoring employees to ensure independent work within timelines, budget, and quality standards. Your duties will involve reviewing RMP/PSUR or any aggregate documents for medical cohesiveness, managing the logistical aspects of safety reports" development, and collaborating with authors from different line functions to meet client and Health Authorities" requirements. You will also be responsible fo...

• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities.Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations In...

Role Name - Sr Medical safety advisor Education qualification - MBBS/MD. Location - Home Based. Work exp - Aggregate Report and Signal Mgt. Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the products safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issu...

Role name - Assoc Medical safety director. Location - Home Based. Education Qualification - MBBS/MD. Experience - Aggregate Report and Signal Management. Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safetys involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousne...

Medical Review aggregate reports (PSUR, PBRER, ADCO & DSUR) and screening of scientific literature for periodic submission as per the Regulations and SOPs. Manage daily workload in conjugation with line manager for aggregate reports generation and any other tasks relevant to the Pharmacovigilance Department. Generation and review of SOPs and WIs and execution of company SOPs. Compliance to project guidelines • Execution of Company Standard Operating Procedures Maintain awareness of changes to/new regulations affecting PVG activities. Trains and mentors new medical reviewers in PVG (if required). To carry out necessary administrative duties required for the job. Other duties as assigned by ma...

Project role : Safety Aggreg Report Spec 1 Work experiences : 2 to 6 years. Work location : Hybrid Must have skills : "Aggregate Report", PBRER, PSUR, DSUR, PADER, "Signal Management", "Signal Detection" Essential Functions : Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. Conduct ongoing signal detection activities as per agreed signaling strategies,...

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 ...

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations In...

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities. Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities. Authoring of Signal Management Reports. Performing literature search and validity check for the aggregate reports. Reconciliation of relevant process trackers. Extraction and validation of data (RSI, Sales, previous reports, RMP, signals). Generation of Line Listings (LL) from safety database Providing reliable support for high priority Ad-hoc activities. Ensure all the reports are drafted within the allocated timelines.

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case clos...

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations In...

Role & responsibilities Contributing to maintain or improve quality performance and compliance of operational PV activities Ensuring Deviation and CAPA Management, Change Control, Document Control, and other Quality Management System activities Developing, managing, and executing quality management processes to ensure quality standards are maintained and compliant with regulatory requirements Coordinating PV audits and Inspections Preparation and management of Pharmacovigilance System Master File (PSMF) Generation, quality review, and distribution of compliance and quality metrics and trending activities. Coordinating compliance, quality, and process improvement initiatives while providing i...

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case clos...

Were Hiring: Specialist Patient Safety Are you a passionate life sciences professional with expertise in Pharmacovigilance and Patient Safety? Location: Mumbai Key Responsibilities: * Draft and review PSURs, PBRER, PADERs, and signal reports (DSR, DEP, SAR). * Author ad hoc safety documents (RMPs, CES, HA responses). * Contribute to ongoing improvement of PV systems & compliance. * Support clinical evaluations and regulatory inspections. * Monitor global PV requirements (Europe & RoW). * Collaborate with cross-functional teams and represent the company at scientific meetings. Qualifications: * MBBS Skills & Experience: * 2+ years in Pharmacovigilance / Drug Safety * Experience with signal de...

Roles and Responsibilities Perform medical review of Individual Case Safety Reports (ICSRs) , Serious Adverse Events (SAEs), and SUSARs Conduct causality and seriousness assessments of adverse events Validate case narratives and ensure medical accuracy and regulatory compliance Participate in safety signal detection and risk evaluation Contribute to the preparation and review of aggregate reports : PSUR, PBRER, DSUR, RMP Support updates to product safety labels (SmPC, PI) based on current safety data Collaborate with regulatory, clinical, and medical affairs teams for cross-functional safety activities Provide clinical input on global pharmacovigilance strategies and safety documents Respond...

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...

Manager - DSRM (Aggregate and SDEA) 1. Managing the Safety Data Exchange Agreement mailbox, to track the emails received and ensure appropriate action is taken. 2. To ensure appropriate agreements are in place with prospective and existing business partners and ensure timely execution and renewal of agreements 3. To liaise with cross functional teams to seek additional information 4. To ensure compliance to the agreements and be audit / inspection ready. 5.Preparing and maintaining the aggregate report writing plan to plan and keep a track of the global aggregate report submissions 6. Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and appropriate co...

We are looking for MBBS - Medical Reviewer with 2-3 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 : Asst. Manager Department : Vigilance Competence Center Gurgaon, Qualification : MBBS/MD with 2-3 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 procedures for medical rev...

Level A4 – 3+ years Associate - Scientific Writing_Aggregate reporting Locations – across any nodal offices/Hybrid **Job Description:** **Responsibilities:** - Responsible for the entire document life cycle, maintaining quality, timeliness, and compliance with internal/client SOPs and regulations. - End-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, PSURs, SUSAR, PADERs/PAERs, ACOs, RMPs , and ad-hoc regulatory and safety reports. - Perform QC review of documents to validate accuracy and relevance, ensuring compliance with client-specific style and global standards. - Assist and mentor junior writers, provide guidance, and ensure consistency and comp...

Job Title - Safety Aggregate Report Specialist 2. Skills required - Signal detection/Signal Management. Years of exp required - 4+ yrs exp in Signal Mgt. Work location - Anywhere in India. Work Mode - Hybrid/Remote. 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. • 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 li...

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 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 (...

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 t...