64 Aggregate Reporting Jobs - Page 3

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties and responsibilities: Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams. People: Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise Performance: Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality Process: Provide medical strategic insights & evaluation related to Company's portfolio. Contribute to the management of the marketing authorization dossiers of the current related portfolio. Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per the defined process Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders : Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the Medical department to ensure relevant & customized are delivered per expectation About you Experience : 5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine Soft skills : Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills) Education : Medical degree MBBS; MD Languages : Excellent knowledge of the English language (spoken and written)

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 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions 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 (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: 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.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: 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. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

Hi We are looking to hire Narrative Medical Writers for our Client. Please go through the JD and Apply Role : Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 365 b) For Position in Bangalore Search : Job Code # 366 c) For Position in Hyderabad Search : Job Code # 367

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

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 closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company. Role & responsibilities 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 Preferred candidate profile Analytical and problem-solving skills. Sound organizational skills Able to work within a team in an open and professional manner Excellent attention to detail and focus on quality Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines. Awareness of global culture and willingness to work in a matrix environment Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs." Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Educational requirements Bachelor/masters degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience Experience Requirements 2+ years experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports

About Navitas Life Sciences: Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider. Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry. Navitas Life Sciences is proud to be an HIG Portfolio company. Website: www.navitaslifesciences.com Expereince : 1-3 Years Skill Set: Signal and Aggregate expereince Responsibilities & functions: Medical Reviewer Aggregate Reports and Risk Management Plans Responsible for the implementation of operational tasks in the field of safety writing Overseeing the service performance Mentoring employees enabling them to work independently within timelines, budget, and quality Review the RMP/PSUR or any aggregate documents for medical cohesiveness Managing all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements/expectations Develops and dispatches project specific slides for both internal and external parties Participate in internal and external audits and inspections by clients and health authorities. Ensure that all trackers related to NLS and client specific procedures are in place and updated on timely basis. Ensures the project team members in completion of all NLS or client specific trainings. Conducts trainings as required for improvement of team performance As required, authors and reviews RMPs, DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports Provides expertise required for the finalization of the RMPs, DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports and its annexes. Resolve issues as they arise. Ensure proper maintenance of all RMPs, DSUR’s, PBRER’s, PSUR’s, PADER’s and Canadian Aggregate Reports Supports in drafting and implementation of NLS or client specific SOPs or WIs. Provides inputs in client specific guidance documents. Acts as Point of contact for NLS aggregate team and client. Signal Management and Risk Management Plans Screening, data mining and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement. Generation of line listings and summary tabulations from Argus/client safety database. Drafting Signal detection, validation, assessment and benefit-risk analysis and prioritisation of signals by reviewing available data. Ensure compliance to appropriate signal SOPs, conventions and guidelines for all activities performed. Tracking of identified signals from regulatory and internal signal detection process and monitoring the status of signals: potential signals, open signals, refuted signals and validated signals. Developing Risk Management Plans and associated activities as per NLS/client specific SOPs Other Responsibilities Assist or support Individual Case Safety Report team as per the workload in respective teams Assist or support Literature review team as per the workload in respective teams Assisting in scheduling of reports assigned to the team Assis Manager/designee in allocation, tracking of reports developed by the team Conduct daily status meetings as required for the projects Support in creating/ updating SOPs as required Ensure team compliance in delivering the reports Qualifications & competences: Graduate or post graduate degree in life sciences, pharmacy, medicine, dentistry, allied health sciences and any additional related courses. Good understanding of medical and Pharmacovigilance terminologies Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations Basic competence with medical and therapeutic terminology. Understanding of patient safety regulatory obligations. Should be familiar with regulatory and pharmacovigilance guidelines. Good command of written and spoken English; additional languages favourable Good knowledge of usual office software (MS Office: Word, Excel, Power point) Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability commitment and capacity for teamwork).

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

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 Internal Relations Educational qualifications preferred Category Bachelor's Degree

Opening for Aggregate Reports , Ahmedabad Role & responsibilities : Authorising of Aggregate reports (PSUR's/PBRER's/PADER's/Annual Reports/ACO/DSUR for submission to local and other Health Authorities. RMP's Pharmacovigilance Updating/Reviewing of Pharmacovigilance system master file (PSMF). Author and review of Periodic Aggregate Safety Reports (PADERs, PSURs, DSU ensuring timely and compliant submissions to global health authorities. Interested candidates shared resume on snehal@topgearconsultants.com