Job Description You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise. Executive - Quality Assurance Company: B. BRAUN MEDICAL (INDIA) Job Posting Location: IN-Chengalpattu Functional Area: Quality Working Model: Onsite Requisition ID: 4599 The purpose / responsible of this position is to support and maintain all documentations requirement of the plan with respect to QMS,IMS,ISO,FDA, regulatory requirement as per the documented procedure Ensure that all key processes in the plant comply with ISO 13485 : 2016 & EN ISO 13485 : 2016 and other GMP requirements Initiate and play key role in customer feedback system Monitor all CAPA processes closely and generate report on weekly basis to make sure the CAPA activities are completed within the stipulated timeline Support continuous compliance to local and corporate documentation requirement with respects to Pharmacovigilance, ISO, CE, India FDA, etc Support the documentation records and maintain its upkeep for the duration of the project and assist in its timely retrieval Safe retention and quick retrieval of all QMS and regulatory records as defined in the organization procedure for the activity Perform and support all validation activities as per validation master plan and main records Responsible to support implementing Occupational Health and Safety (OHS) management systems, processes and procedures that improves the Occupational Health and Safety of the employees and other interested parties in according to ISO 45001 Responsible to support implementation of Environment management systems, processes and procedures in accordance with ISO 14001 Responsible for calibration of tools & measuring devices at internal as well as external source To support in review & updation activities of all ISO, CE, India FDA, validation, regulatory & project related documentation requirement To ensure that change and the current revision status of the documents are identified and relevant version of applicable documents are available at the point of use To ensure that documents remain legible and readily identifiable for a period of time as defined by the procedure Prevent the unintended use of obsolete documents and to apply suitable identification to them for the purpose To ensure proper distribution of the controlled documents and their irretrievability To ensure proper calibration and distribution of the monitoring and measuring devices Make optimal utilization of resources within the given environment and work The position should be able to support & co-ordinate all documentation efforts The position should be well versed in MS office, Adobe Reader / edition etc The position should have good communication & inter-personnel skills to interact with various functions in order to co-ordinate the activities The position should have the skills on learning & applying , customer orientation and be able to work in teams

Company Description Novaspire is a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from Phase I clinical studies to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team of professionals has guided global healthcare companies through GxP compliance challenges by providing solutions and streamlining processes. Role Description This is a full-time on-site role for a Quality Assurance - Clinical Trials and PV professional located in the Greater Bengaluru Area. The Quality Assurance specialist will be responsible for implementing and maintaining quality management systems, conducting quality control and quality assurance activities, ensuring compliance with Good Manufacturing Practice (GMP) standards. Daily tasks will include quality auditing, supporting clinical trial activities, ensuring patient safety, and managing risk. The role involves working closely with multiple stakeholders to ensure the delivery of high-quality clinical research outcomes. Qualifications Experience in Quality Control and Quality Assurance Knowledge of Quality Management and Good Manufacturing Practice (GMP) standards Minimum 4 to 5 Years experience Skills in Quality Auditing and Compliance Strong organizational and communication skills Ability to work effectively on-site in a collaborative environment Bachelor’s degree in Life Sciences, Pharmacy, or a related field Experience in the pharmaceutical or biotechnology industry is a plus Show more Show less

Roles and Responsibilities: Patient Care: Clinical pharmacologists provide specialist advice to colleagues and patients to help improve treatment outcomes and overall patient experience. This may involve optimizing drug therapy, managing adverse drug reactions, and educating patients about their medications. Research and Development: They conduct research to understand the mechanisms of drug action, drug interactions, and the effects of drugs on different individuals, including those with genetic variations. This research can lead to the development of new and improved medicines. Drug Regulation and Policy: Clinical pharmacologists are involved in the development and implementation of regulations and policies related to drug use, including pharmacovigilance (monitoring drug safety) and risk management. Teaching and Education: They play a crucial role in teaching medical students, residents, and other healthcare professionals about clinical pharmacology. Consulting and Advisory Roles: Clinical pharmacologists may provide expert advice to pharmaceutical companies, regulatory bodies, and other organizations on various aspects of drug discovery, development, and use. Job Types: Full-time, Permanent Pay: From ₹20,000.00 per month Benefits: Provident Fund Schedule: Day shift Work Location: In person Application Deadline: 02/06/2025 Expected Start Date: 07/06/2025

As a Consultant, you will be required to address the following: Collaborate in the fulfillment of consulting projects with a special focus on global markets. This will require working closely with other consultants and project managers located in any of our global offices Conduct primary research with healthcare professionals, industry players as well as industry associations, and national agencies Conduct secondary research on large data sets from various data sources Collaborate in the analysis of quantitative and qualitative data for the development of financial models (i.e. eNPV), market models, economic impact models, health-economic models, as well as product adoption and acceptance models Clean, transform, and standardize complex datasets from multiple sources—including EMR, medical and pharmacy claims, and large prescription and healthcare datasets—to ensure consistency and reliability in analysis Design and develop interactive dashboards and reports using Excel and visualization tools (e.g., Power BI, Tableau) to communicate actionable insights to cross-functional team Develop market landscape presentations, market entry strategies, product positioning strategies, and others Work to solve complex business problems Participate in meetings and presentations to clients across the globe Engage in regular global training modules and required Pharmacovigilance training (internal and client-specific) Qualifications A minimum of 2-3 years of demonstrable experience within the healthcare industry in roles related to market insights/analytics, product management, strategy consulting or related roles Education: Master’s degree in Biotechnology, Pharmacy (MPharm), Bioengineering/Biomedical Engineering, Business Administration, or a related field Marketing, management consulting and/or market research, and reimbursement/pricing expertise are a plus Flexibility to work within a multicultural interdisciplinary team across various time zones Fluent in English and preferably speak other foreign languages. Self-motivated with exceptional organizational skills Advanced degree (PhD) a plus Show more Show less

Hi We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Description 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 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

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 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

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 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

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of trainings Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Cases Rave, CDM (startup, close out, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the back-log. Training to new team members as and when required. Key Skills: a) Minimum 3 years of Experience in leading clinical studies/ Clinical Data Management b) Hands on experience of Study Conduct and Close Out is must c) Any Graduate 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 # 95 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 98

Hi , WE are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data. 6. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. 7. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. 8. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. 9. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) 10. Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable 11. Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), 12. EDC build and/or clinical data management experience preferred 13. Experience in AWS preferred 14. Experience setting up automated validation is preferred 15. Knowledge of Data lake and creating interactive Dashboards are preferred 16. Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) 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 ( Nagpur ) Type : Job Code # 85 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 86

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 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

Hi We are looking to hire Medical Data Reviewer for our Client. Please go through the JD and Apply. Responsibilities: Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members Qualifications: Bachelor/ Masters degree or equivalent in Life sciences/ Alternative Medicine (preferred) Eligibility: Good English communication skills Experience of handling clinical trial/ safety data - > 4 years 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 # 359 b) To Apply for above Job Role ( Pune ) Type : Job Code # 360 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 361

Hi We are Hiring for the job role of Medical Writer Job Description: * Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. * Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. * Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. * To work in coordination with all the members in the study team- internal and external for the development of clinical documents. * Share project timelines amongst the study team for the development of document. * Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. * Review statistical analysis plans and table/figure/listing, when required. * Ensure uniformity and consistency in the scientific content of the regulatory documents * Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. * Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. * Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. * Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. * Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. * Plan and organize project and non-project meetings, as and when required 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 # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

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

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 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 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 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

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 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 # 365 b) To Apply for above Job Role ( Bangalore ) Type : Job Code # 366 c) To Apply for above Job Role ( Hyderabad ) Type : Job Code # 367

Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT && HCPCS. As per HIPAA rules healthcare providers need efficient Medical Coders. Qualification & Specifications : MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry). 2020 -2024 passed out Skills Required: * Candidates should have Good Communication & Analytical Skills and should be Good at Medical Terminology (Physiology & Anatomy). Role: To review US medical records Initial file review for identifying merits Subjective review and analysis to identify instances of negligence, factors contributing to it To review surgical procedures, pre and post-surgical care, nursing home negligence To prepare medical submissions To prepare the medical malpractice case Regards Vinodhini 9880650498

Role: Senior Medical Safety Advisor Work Experience: 5+ Years. Clinical Experience: 3+ Years. Pharmacovigilance/PV Experience : 2+ Years Work location: PAN India Work Mode: Home Based Must Have Skills: Pharmacovigilance, ICSR. 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 product’s 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 issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. 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, seriousness, causality, and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective. Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectedness, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24-hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications MBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required. Three plus (3 + years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training is required. Two plus (2+) years of pharmacovigilance experience is required. Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR. In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works preferred. Show more Show less

ASTER DM HEALTHCARE LIMITED is looking for Senior Pharmacist to join our dynamic team and embark on a rewarding career journey. Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

ASTER DM HEALTHCARE LIMITED is looking for Senior Pharmacist to join our dynamic team and embark on a rewarding career journey. Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

ASTER DM HEALTHCARE LIMITED is looking for Senior Pharmacist to join our dynamic team and embark on a rewarding career journey. Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Job Post :- Salesforce PV Consultant Experience :- 4+ years Location - Remote Duration - 6 months contract Job Summary: We are looking for a skilled Salesforce Consultant with a strong background in Pharmacovigilance (PV) and hands-on experience in the Healthcare industry. The ideal candidate will work closely with business and technical teams to enhance Salesforce solutions that support PV processes, regulatory compliance, case tracking, and safety reporting. Key Responsibilities: • Analyze and understand business requirements related to Pharmacovigilance and safety case management. • Configure and customize Salesforce to support PV workflows including case intake, triage, assessment, reporting, and follow-up. • Work with stakeholders from Regulatory, Safety, and Compliance teams to optimize processes within Salesforce. • Develop and manage Salesforce reports and dashboards tailored for PV activities and compliance monitoring. • Collaborate with QA and validation teams to ensure system compliance with GxP and other regulatory standards. • Ensure data integrity, user access control, and audit readiness for PV-related modules in Salesforce. • Troubleshoot issues, manage incidents, and support user training and documentation. Required Skills and Qualifications: • Minimum 4 years of Salesforce experience, with at least 2 years in PV/Safety applications within the Healthcare or Life Sciences domain. • Solid understanding of Pharmacovigilance processes, global safety regulations (e.g., FDA, EMA), and GVP guidelines. • Proficiency in Salesforce customization: workflows, flows, validation rules, custom objects, Lightning pages, etc. • Experience working with Salesforce Health Cloud or custom implementations for healthcare use cases. • Familiarity with case safety report generation, regulatory submission formats, and safety data lifecycle. • Strong analytical and communication skills, with the ability to liaise between technical and business stakeholders. Preferred Qualifications: • Salesforce certifications (e.g., Salesforce Administrator, Health Cloud Consultant). • Knowledge of tools such as Argus Safety, ArisG, or other safety databases (nice to have). • Experience working in validated environments with exposure to 21 CFR Part 11 compliance. • Prior experience in Agile/Scrum delivery environments. Show more Show less

ASTER DM HEALTHCARE LIMITED is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

JOB_DESCRIPTION.SHARE.HTML CAROUSEL_PARAGRAPH JOB_DESCRIPTION.SHARE.HTML India - Bengaluru Medical & Safety No Regular Full-Time 2524 Emmes Global mail_outline Get future jobs matching this search or Overview Job Description Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us! Primary Purpose The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements. Responsibilities Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members. Reviews safety events. Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources – clinical (both interventional and non-interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc. ▪ Provides first line evaluation of serious adverse events (SAEs). Communicates with site staff regarding reported AEs or SAEs to gather additional information. Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports. Coordinates the timely completion and submission of required reports to health authorities and business partners. ▪ Maintains ongoing database of SAEs and reconciles SAEs in the database as needed. Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis. Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary. Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and noninterventional). Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary. Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports. Coordinates with project staff. Participates in project team meetings for the planning, preparation, and development of all safety-related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs. Contributes to the development and implementation of safety-related Case Report Forms (CRF) and SaMP. Ensures maintenance of documentation required by both corporate and project SOPs. Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities. Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable. Guarantees compliance and adherence to the quality standards. Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned. Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract. Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures. Completes all relevant professional training in the given scope and time frame. Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross-department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives. Performs other duties as assigned. Qualifications Bachelor’s degree in pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice (e.g., pharmacy, inpatient or outpatient healthcare facility, or clinical research center, etc.). At least 2 years of related experience in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) Experience in safety monitoring/pharmacovigilance is preferred. The readiness to work in a regulated environment and understanding of the Good “x” Practice (GxP) principles. Ability to learn and understand quickly. Consistency, quality, compliance and patient centricity respected as key values. Excellent clinical judgement and ability to communicate moderately complex clinical issues in a scientifically sound and understandable way. Detail-oriented with good organizational skills Ability to work as a team member and function on a cross-functional team. Excellent verbal and written communication skills. CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes Show more Show less

Job title: Pharmacovigilance Case Quality Oversight Expert Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Main Responsibilities About the job: The PV Case Quality Oversight Expert is in charge to analyze Quality data related to ICSRs and to contribute to processes improvement related to Case Management (CM) & Medical evaluation. Responsible for ensuring ICSR submission compliance and ICSR quality compliance is achieved by performing oversight activities as applicable ICSR quality analytics and process related activities for case management Analyze in-process quality checks (QC), reporting of results, tracking quality findings, metrics against, defined KPIs and implement actions provided by Global PV case quality lead. Analyze ICSRs quality data of in-line workflow QCs/ off-line QCs (e.g., correction requests). Analyze quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness. Adjudicate findings accuracy. Drive continuous process improvement for CM by partnering with all entities, Country Safety Leads (CSL), License Partners, and vendors. Responsible to compare various quality metrics and provide comprehensive Quality analysis with action items Oversee Quality CAPA management for CM Investigate associated root causes and proposes CAPAs. Identify ICSRs trends, prepares, or coordinates preparation of ICSRs Quality report. Participate in CAPAs elaboration (e.g., trainings, QDs updates and user manual). Monitor CAPAs implementation and assess CAPAs effectiveness. Participate in vendor quality oversight activities, liaise regularly with vendors, and ensure quality consistency across CM functions. Lead or contribute to the Case quality review meetings for ICSRs where trends are presented, CAPAs proposed or discussed, efficiency assessed. Communicate analysis results to the CM / CSE PV community. Oversee the in-process workflow of all ICSRs and implementing strategies to prevent late ICSR reports. Create and maintain CAPA records to be provided for inspections/ audits. Review and create SOPs, job aids, etc for case management activities Other PV tasks as required. Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Overall 6+ years of experience, with minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in handling Quality events, CAPA, Deviations Experience with QMS. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Strong experience in ICSR quality review, submissions, CAPA, Deviation Management, RCA and trending analysis. Strong experience in effectives checks and trending analysis of the effectiveness check. Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Education Bachelor’s degree in pharmacy / Life Sciences / or equivalent Academic qualification is desirable with 5 years’ experience in PV Quality for case management Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less