683 Meddra Jobs - Page 8

What you will do In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars (mandate) Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy...

Role Description: The Scientific Communications MLR Technical Reviewer is responsible for checking all medical content for data and scientific accuracy, and reference appropriateness for materials submitted through the Medical, Legal, and Regulatory (MLR) process. This role ensures that all content adheres to Amgens scientific and compliance standards, while supporting timely review and approval of assets that inform and engage healthcare providers, patients, and internal stakeholders. Working closely with the US Scientific Communications MLR Reviewer, the Technical Reviewer brings scientific expertise, attention to detail, and compliance awareness to evaluate the submissions. This role cont...

Medcare Hospitals Medical Centres is looking for Charge Nurse - Nursing Services to join our dynamic team and embark on a rewarding career journey. Supervise nursing staff in a hospital or clinical settings. Oversee patient care, make management and budgetary decisions, set work schedules, coordinate meetings, and make personnel decisions. Recruit and train nurses and other health care professionals and maintain a facilitys records. Work with staff to apply emerging nursing theories to care delivery. Also implement state and federal regulatory guidelines for patient safety and educate staff about any changes in the laws and how they impact care delivery. Disclaimer : This job description has...

The GSSS will report to the GSSS Team Leader (India) and interact with the Clinical Supply Chain stakeholders. Main responsibilities include: Common: Clinical Trial & Supply Knowledge Understandingof clinical trial design, protocols, regulatory requirements (GxP) Understandingof clinical endpoints, patient randomization processes, study arms, dosing regimens, cohort management, stratification factors Understandingof investigational product management in clinical trial including kit types, shelf life, IMP production plan, depot management, IMP distribution, IMP reconciliation, returns/destruction. Level 1 responsibilities: Create and manage transfers to depot in IRT, customize them in Sanofi ...

Employment Type: Full time, Regular, Hybrid work arrangement Roles and Responsibilities Primary Duties Ready to work in 24/7 shift timings. Excellent communication (written and oral) and interpersonal skills Monitor security systems and networks for suspicious activity. Validating alert triggered by security information and event management (SIEM) tools. Triage events and investigate to identify security incidents. Investigate security incidents and determine their severity. Contribute to incident response, maintaining relevant communication and information in emails, ticket summaries, analysis and reporting. Escalate security incidents to the next level for further investigation. Make recom...

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whil...

Support Associate Director ESP Engagements for the setup of new global ESPs. Support Associate Director ESP Engagements with contract setup & management. Support ESP account management including but not limited to GDDB account, Citrix account, maintenance of dashboard & data etc. Collaborate and support PS&PV QA in QMS implementation for outsourced activities. Support ESP Engagements team for the implementation of ESP governance and oversight of the outsourced activities. Support oversight of process improvement and innovation initiatives at ESPs. Act as Point of Contact (POC) for ESP IT issues. Supports ESP Engagements team to supervise compliance and quality of ESPs performing activities o...

Assist the Principal Investigator in fieldwork, data collection, and analysis. Draft, refine, and administer research tools such as questionnaires and interview schedules. Conduct literature review and support preparation of research reports. Coordinate with participants, stakeholders, and institutions relevant to the project. Assist in documentation, progress reports, and dissemination of project findings.

Gather and influence eCOA design specifications from Clinical Trial Protocol to enable successful trial design and implementation As a Clinical database programmer, build, program and test Clinical trial data collection systems (eCOA database) and associated data repository mappings for a trial or set of trials within a program using data standards library components Ensure Clinical data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives Partner with translation vendors to implement localized data collection in country specific language Partner with Clinical Build Programmer to ensure complete data build for trial data ...

Collaborate with stakeholders to develop and update processes and standards that will drive greater effectiveness and efficiencies globally Ensure stakeholders are informed and understand upcoming system and process changes that impact their business including value added. Collaborate with training manager to ensure training needs of end users are met. Oversee and participate in testing, validation of systems and processes as needed Monitor applicable regulatory requirements; assure compliance with Baxter and external standards May enter data into system or run data reports as needed SME in areas such as RIM-Veeva Vault, CCDS, XEVMPD/IDMP and Regulatory information quality management Maintai...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Delivery Lead Manager Qualifications: MD Years of Experience: 13 to 18 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patie...

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by conv...

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by convergin...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy Years of Experience: 1 to 2 year About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accentu...

We are looking for a highly skilled and experienced Pharmacist to join our team at MAX Hospital in Noida. The ideal candidate will have 3 to 8 years of experience in the pharmaceutical industry, with a strong background in pharmacy practice. Roles and Responsibility Dispense medications to patients and provide counseling on their proper use. Manage inventory and maintain accurate records of prescriptions and dispensing activities. Collaborate with healthcare professionals to develop and implement medication therapy plans. Conduct patient assessments and monitor their response to medication therapy. Develop and implement pharmacy protocols and procedures. Participate in quality improvement in...

We are looking for a skilled Medical Writer with 5-10 years of experience to join our team in Hyderabad. The ideal candidate will have excellent writing and editing skills, with the ability to create clear, concise, and engaging content. Roles and Responsibility Develop high-quality medical content, including articles, blogs, and other written materials. Conduct research and analyze complex scientific concepts to create accurate and informative content. Collaborate with cross-functional teams to ensure consistency and quality of content. Edit and proofread content for clarity, grammar, and punctuation. Stay up-to-date with industry trends and developments in medical science and technology. P...

Immediate Openings on Business Consultant _ Gurgaon_Contract Skill: Business Consultant Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description Top 3 skills which is mandatory Aris, BPM, Functional and Technical Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, lice...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to li...

Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions SBO strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally Main responsibilities: The overall purpose and main responsibilities are listed below: Responsible for project management support to the scientific writer ensuring the end-to-end effective project delivery of the designated publication/medical education deliverable across all phases Initiate and amend submission based on c...

Main responsibilities: The overall purpose and main responsibilities are listed below: Responsible for project management support to the scientific writer ensuring the end-to-end effective project delivery of the designated publication/medical education deliverable across all phases. Initiate and amend submission based on comments (as required). Support the writer with internal and external stakeholder communication. Track the delivery of activities (including managing issues and risks) and support follow up. Support required submission, compliance/ approval activities, and ensure compliance with publication processes and end-to-end publication management tools (e.g., iEnvision - previously,...

Exp 4–6years in healthcare/pharma BPO ,U.S. Healthcare Technical Knowledge Proficiency in LOINC, ICD-10, CPT, NDC, RxNorm, SNOMED CT. Tools & terminology tools (Symedical, Clinical Architecture), EHR/EMR system Geetha : 9902419093

As a Medical Coding Specialist at Statistics & Data Corporation (SDC), you will be responsible for coordinating the coding of terms for clinical trials. Your role will involve manually encoding medical terms, ensuring consistency in coding across projects, and communicating effectively with the coding team and Manager, Medical Coding. **Key Responsibilities:** - Manually encode medical terms not automatically coded by the data management system - Ensure consistency in coding terms within and across projects - Communicate timely and effectively with coding team and Manager, Medical Coding regarding any issues, risks, concerns, or technical needs - Contribute to and review Data Management Plan...

Job Overview The RN Associate / Senior Associate, Clinical Data Management is responsible for delivering and overseeing clinical and patient reported data within electronic data capture (EDC) platforms, including iTakeControl. Activities include monitoring databases and video evidence, maintaining data quality, and database integrity for research studies from conception to closeout. The role will work closely with the Clinical Operations, Product Management and Technical Delivery teams and is responsible for detailed specification development, documentation, and supporting clinical operations, project management and delivery activities for Clinical and iTakeControl (iTC) product client proje...

Contribute to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support Aggregate Report related activities. Maintenance of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e. g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related docum...

Job Overview The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, case follow-up,database entry, review and submission to applicable regulatory authorities within stipulated timelines. Required Candidate profile Any Pharmacy or Pharm D with Certification in Pharmacovigilance can Apply Should have Good Communication Skills Should have strong knowledge on Argus Safety Database and Case Processing and MedDRa