215 Meddra Jobs

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system in terms of medical review of safety cases and management of safety signals. Key Responsibilities: - Conduct medical review of ICSRs, including assessment of Literature cases and authoring of enhanced MAC. - Support safety lead in authoring medical assessment letters based on the bi-annual/six-monthly line listing. - Perform literature review of assigned articles and assist in the review of articles for inclusion in PBRER, DSUR, IB, etc. - Provide support to Therapeutic Areas as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents. - Assist in monitoring the safety profile of products, including activities such as literature review, medical review of individual cases, and medical evaluation of quality defects. - Co-author the PBRER and provide medical inputs to specific sections, including follow-up activities on HA assessment reports. - Contribute to the medical sections of DSUR, IB, labeling documents, Product Guidance Documents, and Expert Statements. - Support signal detection and evaluation activities for assigned products. - Assist in the preparation of Health Authority queries and other safety-related documents. - Act as a Subject Matter Expert for Medical Function processes and provide support during audits and inspections. - Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities. - Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality. - Assist in the development and optimization of training materials and deliver training to Novartis staff and external stakeholders. Minimum Requirements: - Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in relevant field, or Medical Degree (MBBS or MD) required. - Minimum 3 years of experience in the pharmaceutical industry or related field. - Experience in safety document or medical writing, including proficiency in coding with MedDRA and WHO dictionaries. - Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology. - Attention to detail and quality focus. - Strong organizational and project management skills. - Excellent communication skills and ability to operate effectively in an international environment. - Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. - Technical understanding of Biomedical/Biostatistics concepts and strong problem-solving skills. - Good presentation skills. - Proficiency in computer skills, including creating spreadsheets, templates, presentations, and working with safety databases/applications. - Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.,

We're Hiring: Junior Pharmacovigilance Specialist Location: Pune | Full-Time | Entry-Level / 01 Year Experience Are you a Life Science or Pharmacy graduate looking to kickstart your career in Pharmacovigilance Join our growing team and play a key role in ensuring drug safety and patient well-being through adverse event reporting and regulatory compliance, ???? Role Highlights ?? Analyze & process adverse event reports ?? Prepare regulatory safety submissions ?? Follow GCP, GDP, ICH & MedDRA coding standards ?? Collaborate with project managers and team leads ?? Ensure data accuracy and audit readiness ???? What Were Looking For ??? B Pharm / M Pharm Graduates ???? Freshers ???? Familiarity with MedDRA, CTC, MS Office, PubMed/Embase ???Excellent communication and documentation skills ???? Team player with strong attention to detail ???Apply Now medexcode /careers Show

Looking for a motivated individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience. Roles and Responsibility Conduct thorough medical reviews of patient records and reports to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and maintain expertise in medical terminology, regulations, and guidelines. Provide high-quality support to internal stakeholders through effective communication and documentation. Stay updated with changes in regulations and guidelines affecting medical review processes. Participate in quality improvement initiatives to enhance the efficiency and effectiveness of medical review activities. Job Requirements Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a team environment and communicate complex information clearly. Proficiency in using electronic health records systems and other healthcare software applications. Strong organizational and time management skills with the ability to prioritize tasks and meet deadlines. Commitment to delivering high-quality results and maintaining confidentiality and professionalism. Omega Healthcare Management Services Private Limited is a leading provider of healthcare management services, committed to delivering exceptional care and customer satisfaction. We are an IT-enabled services company that uses technology to improve healthcare operations and outcomes.

As a Clinical Data Coder 1 specializing in MedDRA and WHODD, with 2-5 years of work experience, your primary responsibility will be to provide comprehensive data management expertise to the Data Management (DM) team for meeting sponsor and company needs. You will be involved in performing Clinical Data Management and/or Coding activities, taking on leadership roles such as Lead Coder or Data Operations Coordinator (DOC) for specific CDM tasks, or leading coding tasks on mega trials. In this role, you will independently manage coding activities and projects throughout the full study life-cycle, ensuring high quality and timely delivery with minimal guidance. Your responsibilities will include validating and testing coding applications and reports, conducting data review, resolving data clarifications, and managing coding project timelines under the guidance of the DOC or Data Team Lead (DTL). Additionally, you will be involved in Serious Adverse Event (SAE) reconciliation activities, performing quality control procedures, and assisting in the implementation of new technology related to coding and data management. You will also be expected to handle audit requirements for studies, maintain compliance with core operating procedures and work instructions, and collaborate effectively with the study team. To excel in this role, you should hold a qualification in Pharmacy, dental, medical, nursing, life sciences, or a related field, with excellent knowledge of medical terminologies, pharmacology, anatomy, and physiology. You should possess in-depth knowledge of medical dictionaries such as MedDRA and WHODD, and have a solid understanding of the Data Management process from study start-up to database lock. Your ability to bring coding and project-related solutions to the DM team, maintain good communication within the team, and adapt to changing requirements will be crucial for success in this position. Your dedication to meeting objectives as assigned, along with your attention to detail and commitment to quality, will contribute to the overall success of the data management processes within the organization.,

Hiring | Full Stack .NET Developer Location: Hyderabad / Remote Contract Position Share your resume with Current CTC, Expected CTC & Location to: [your email here] Job Title: Full Stack Developer (.NET) Experience: 5+ Years Work Mode: Remote (Hyderabad preferred) Contract Duration: [Specify duration or ""Long-term/Extendable""] We are looking for a seasoned Full Stack Developer with extensive experience in .NET technologies, RESTful APIs, and Windows Services. This role requires a sharp problem-solver who can work independently, translate business needs into technical execution, and deliver high-performance applications. Key Responsibilities: Develop scalable applications using .NET (C#) with REST APIs and Windows services Design and implement robust, maintainable back-end architecture Apply solid relational and dimensional database design principles Collaborate with cross-functional teams in an Agile/Scrum environment Break down business requirements into clear, actionable technical tasks Maintain code quality through reviews and unit testing Support DevOps processes for CI/CD if applicable Required Skills: 10+ years of experience in .NET/C# application development Strong understanding of REST API design and Windows services Proficiency in SQL Server or equivalent RDBMS systems Experience working with Agile methodologies Excellent communication and analytical skills Ability to work with minimal supervision Preferred Skills (Good to Have): Experience in pharmaceutical R&D, clinical systems, or healthcare IT Familiarity with medical coding standards (e.g., MedDRA, SNOMED, LOINC) Exposure to DevOps pipeline tools like Bitbucket, Jenkins, UrbanCode Deploy Understanding of regulated environments (e.g., GxP, CFR Part 11)

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 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.accenture.com 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 patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug saftey associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years Language - Ability: English(Domestic) - Intermediate 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.accenture.com 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 whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Ability to handle disputesAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BCom

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 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.accenture.com 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 patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety AssociateDrug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

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 initiatives to enhance patient care and safety. Job Requirements Hold a degree in Pharmacy (D.Pharm, B.Pharm, M.Pharm) from a recognized institution. Possess a minimum of 3 years of experience in pharmacy practice, preferably in a hospital setting. Demonstrate strong knowledge of pharmaceuticals, medications, and medical terminology. Exhibit excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and prioritize tasks is essential. Strong analytical and problem-solving skills are required.

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 3 to 5 years 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.accenture.com 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 world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years 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.accenture.com 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 whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Ability to establish strong client relationshipAbility to handle disputes Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

The Infection Control Nurse at Manipal Hospitals will be responsible for monitoring and preventing infections within the healthcare facility. This role involves developing and implementing infection control policies, protocols, and practices to ensure the safety of patients, staff, and visitors. The nurse will conduct regular training sessions for healthcare personnel to promote awareness of infection control measures. Additionally, the Infection Control Nurse will collect and analyze data related to infection rates, investigate outbreaks, and report findings to the healthcare team and relevant authorities. Collaborating with multidisciplinary teams will be crucial for achieving the organization's infection control goals. Key Responsibilities: - Monitor and track infection rates and trends within the hospital. - Develop and implement evidence-based infection prevention and control policies. - Conduct regular audits and inspections to ensure compliance with infection control standards. - Provide education and training to healthcare staff on infection prevention practices. - Investigate infection outbreaks and implement appropriate control measures. - Maintain accurate records and documentation related to infection control activities. - Educate patients and their families on infection prevention strategies. - Collaborate with healthcare professionals to improve patient outcomes related to infections. Skills and Tools Required: - Registered Nurse (RN) license and a valid nursing practice certificate. - Certification in Infection Control (CIC) is preferred. - Strong knowledge of infection control practices and healthcare regulations. - Excellent analytical and problem-solving skills. - Strong communication and interpersonal skills for effective staff education and patient interaction. - Proficiency in data collection and analysis related to infections. - Familiarity with infection control software and electronic health records systems. - Ability to work in a fast-paced environment and manage multiple priorities. - Attention to detail and commitment to maintaining high standards of patient care. This position offers an opportunity to make a significant impact on patient safety and quality of care within a prestigious healthcare organization. Roles and Responsibilities About the Role: The Infection Control Nurse at Manipal Hospital, Yelahanka, plays a crucial role in preventing and controlling the spread of infections within the healthcare facility. This position involves implementing infection control policies, conducting training programs, and monitoring compliance with established protocols. You will work closely with various departments to ensure patient and staff safety while maintaining high standards of care. About the Team: You will be part of a dedicated and multidisciplinary team focused on enhancing patient safety and quality of care. The team consists of healthcare professionals who continuously collaborate to address infection prevention challenges. This supportive environment encourages knowledge sharing and professional growth while prioritizing the health and well-being of patients and staff alike. You are Responsible for: Conducting regular surveillance of infection rates and identifying areas for improvement. Developing and implementing infection prevention protocols and training programs for staff. Conducting audits and assessments to ensure adherence to infection control practices. Collaborating with healthcare providers to manage outbreaks and implement control measures. Providing education and resources to patients and families regarding infection prevention. To succeed in this role – you should have the following: A relevant nursing degree and certification in infection control or epidemiology. Strong knowledge of infection control practices, standards, and regulations. Excellent communication and interpersonal skills for effective collaboration. Analytical skills for data collection and interpretation. A proactive approach to problem-solving and the ability to work in a fast-paced environment.

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 4 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 4 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 2 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 2 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Role & responsibilities The responsibilities of the role include processing Individual Case Safety Reports (ICSRs) and conducting literature screening activities. The candidate will be responsible for reviewing and assessing the validity of literature abstracts and articles, with further processing into the safety database as required. Additionally, the role involves maintaining the Extended Eudravigilance Medical Product Dictionary (XEVMPD) and performing EVWEB updates, including revisions to the Summary of Product Characteristics (SPC/SmPC) and Patient Information Leaflets (PILs). The candidate will also perform comparative reviews of SmPC and PIL documents against reference products. A key responsibility includes the preparation and maintenance of Risk Management Plans (RMPs), which involve identifying potential risks, outlining mitigation strategies, and ensuring regulatory compliance. Continuous monitoring of safety updates and detection of safety signals for client products is essential. All activities must be conducted in strict compliance with standard operating procedures (SOPs) and applicable regulatory requirements. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, and EVWEB Updates Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) Risk Management Plan (RMP) and Regulatory Documentation ICSR Processing and Reference Product Comparison

Role & responsibilities We are seeking a Pharmacovigilance Associate with 2 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in processing Individual Case Safety Reports (ICSRs) and performing literature screening to identify safety information. This includes assessing validity of literature abstracts/articles for database entry. The role also involves maintaining XEVMPD, performing EVWEB updates, revising SmPCs, PILs, and preparing Risk Management Plans (RMPs). Monitoring safety updates/signals and ensuring SOP & regulatory compliance is essential. Preferred candidate profile Eudravigilance, XEVMPD Maintenance, EVWEB Updates, SmPC (Summary of Product Characteristics), PIL (Patient Information Leaflet), Regulatory Documentation, Reference Product Comparison, ICSR Process,

ProductLife Group is looking for Medical Reviewers, having 3-4 years of experience with MBBS/MD degree. Responsibilities: We are looking for a medical reviewer proficient in post-marketing drug safety. Post-Marketing (Pharmacovigilance) Medical review of the ICSRs (Spontaneous, literature, clinical studies) Support in seriousness assessment, Initial Triage Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. perform additional review of cases to ensure competency. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members on good assessment of the cases and MedDRA coding Required Education: MBBS, or MD (Doctor of Medicine) Required Experience: Client communications Safety Database experience Minimum 3-4 years experience working for service providers or pharmaceutical company in Pharmacovigilance department Additional experience and/or skills:: Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team. Clinical experience an advantage Ability to deliver constructive feedback Emotional intelligence Adaptability Analytical skills Flexibility Reliable Strong organisation skills Punctual Database experience

Clin Infotech is offering the internship opportunity for BDS MDS Dental Graduates Should have Knowledge in Pharmacovigilance Should Have knowledge on Argus & MEDDRA Applicants Should Complete Certification in Pharmacovigilance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. About the Role Key Responsibilities Structured Data Submissions (SDS): Independently perform timely SDS (e. g. xEVMPD, IDMP) via RIM system, ensuring data quality and exchange with EMA including analysis and tracking of 3rd acknowledgements. Ensure Data Quality Management and timely delivery of requests for new/changes of code lists/terms including external reference data (e. g. SPOR). Provide guidance and support to cross-functional teams related to planning, submission compilation and dispatch of worldwide compliant SDS, as well as submission filing strategy, eCTD document lifecycle management and workflows, in alignment with FHIR (Fast Healthcare Interoperability Resources). Assess SDS resources and support needs and develop/implement solutions to create efficiencies. Effectively troubleshoot technical/quality issues relating to compilation, validation and dispatch of global submission outputs. Coding of Clinical Particulars: Perform coding of the Clinical Particulars attributes in Novartis Regulatory Information Management (RIM) system: Therapeutic Indications and Co-morbidity using the MedDRA dictionary, Intended effect using a controlled vocabulary, as required to ensure compliance with xEVMPD / IDMP requirements. Review and maintain MedDRA code values used in EU registrations upon MedDRA version updates by performing gap analysis of changes, and update existing values accordingly in RIM system. Review and update coding values as needed upon queries from the European Medicines Agency (EMA), for instance receipt of 3rd acknowledgment. Interactions: Liaise with GDD colleagues regarding new regulatory requirements and related business processes, to ensure proper knowledge transfer to IT business partners for system enhancement requests. Manage interactions and collaboration with RA Country Organisations (CO), Global RA and non-RA functions on regulatory and compliance maintenance activities for Authorised and Investigational medicinal products. Optimally support QPPV and PV-related processes (incl. fees), provide support for internal /external audits /inspections. Facilitate and/or participate in meetings with internal and external stakeholders (including acquisitions, partnerships and divestiture efforts). Participate as key business contributor in Technology initiatives including, but not limited to, systems upgrades, validation, implementation activities and functionality enhancements, including external service providers. General & Training: Support user training of RA end users, as required, Coach / mentor new team members. Support PQ testing and Application verification activities, as required. Support preparation of administrative procedures and Working Instructions to support system implementations. Develop, implement, and support innovative regulatory strategies and life-cycle management of RA systems, including process productivity and efficiency improvement and propose potential solutions. Identify and investigate operational needs, problems, and opportunities, contribute to the implementation of improvements within area of responsibility. Minimum requirements BS in Life Sciences (Medicines/Pharmacy) or a relevant discipline with at least 7 years of professional work experience. Master s degree preferred (M. Pharma or MD). 4-6 years of relevant experience in structured data submissions (e. g. xEVMPD) and use of RIM systems, including familiarity with submission publishing activities. 3-5 years in Clinical coding (e. g. MedDRA, SNOMED), Labelling, Regulatory Affairs or Regulatory submission related experience. WITH SDS experience as 1st bullet, Proficient knowledge of EMAs databases (e. g. SPOR). Knowledge and experience with eCTD, xEVMPD, IDMP, Publishing Standards and applicable related tools is desirable. Experienced in using RA systems of data (RIMS, DMS, Change Control databases), systems data model and vocabularies. Familiar with the drug development and registration process. Solid project management, organizational and time management skills to manage multiple ongoing projects simultaneously. Familiar with global Health Authority regulations/guidelines e. g. , FDA regulations, ICH and EMA guidelines/directives. Proficiency with computer programs/systems (MS office, etc. ) with demonstrated ability to learn new systems quickly. Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? 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As a Data Review Associate at our rapidly growing corporate activities, you will be based in Pune and join our Global Clinical Coding & Support team. You will play a crucial role in accomplishing tasks and projects that are vital to the company's success. This is an exciting opportunity for you to utilize your previous nursing expertise and further develop your career. Your responsibilities will include conducting comprehensive manual reviews of clinical data collected in trials, developing clinical review guidelines for specific therapeutic areas, and collaborating with the Data Management team to ensure query resolution. You will specialize in therapeutic areas such as Oncology, Hematology, Infectious Disease, Endocrinology, and Metabolic disorders. To qualify for this role, you should hold a Bachelor's Degree in Nursing/Medicine or a more advanced clinical degree. Professional/Post-Qualification Nursing experience, preferably in Oncology and Hematology, is preferred. You should also possess general knowledge of clinical trial processes and/or experience working with clinical data. Experience with using MedDRA and WHO Drug dictionaries will be considered a plus. Medpace is a full-service clinical contract research organization (CRO) dedicated to providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We are committed to accelerating the global development of safe and effective medical therapeutics through our scientific and disciplined approach. With headquarters in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries. Joining Medpace means being part of a team that has positively impacted the lives of countless patients and families facing various diseases. You will contribute to improving the lives of individuals living with illness and disease in the future. As a Medpace employee, you will enjoy a flexible work environment, competitive compensation and benefits package, competitive PTO packages, structured career paths with opportunities for professional growth, company-sponsored employee appreciation events, and employee health and wellness initiatives. Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024. We have also received CRO Leadership Awards from Life Science Leader magazine for our expertise, quality, capabilities, reliability, and compatibility. If you are interested in this opportunity, a Medpace team member will review your qualifications and reach out to you with details on the next steps. Join us at Medpace and make a difference tomorrow!,

We are hiring!! Open Position : Drug Safety Associate - 1, with a minimum of 1 year experience in case processing. Location : Initially work from home, later will be office based Salary Upto : 4 Lakhs INR per annum Qualifications: Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D) Experience: 1 to 2 years of experience in PV (Pharmacovigilance) Roles and Responsibilities: As Quality Check Reviewer Review data entered in safety database for completeness and accuracy. Provide quality feedback to team resources Track and maintain quality metrics As Case Processor Responsible for data entry of Individual case safety reports into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all incoming cases in order to meet timelines. Full data entry including medical coding and safety narrative. As Medical Coder Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). As Narrative Writer Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Other responsibilities: Following up with sites regarding outstanding queries. Follow up on reconciliation of discrepancies. Follow departmental AE workflow procedures. Closure and deletion of cases. Mentor and guide the activities of the Drug Safety Associate. High level of proficiency al all workflow tasks. Perform any other drug safety related activities as assigned. Specialized knowledge and skills: Basic competence with medical and therapeutic terminology. Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team. Understanding of patient safety regulatory obligations. Should be familiar with regulatory &pharmacovigilance guidelines. Should be familiar with pharmacovigilance terminology. Excellent attention to detail. Ability to deliver within established timelines. Fluency in English and excellent comprehension. Computer literate. Relevant product and industry knowledge. Experience with relevant software applications. Communication skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective crossdepartment communication. Ability to document and communicate problem/resolution and information/action plans. Desired technical skills: Person should be familiar with MS Office Tools. Safety database knowledge. Compliance : Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures. Additional Skills Strong motivational skills and abilities, promoting a team-based approach. Strong interpersonal and communication skills, both verbal and written. Strong organizational and leadership skills. Goal-oriente and ability to maintain professional and positive attitude.

We are looking for a skilled OT Technician to join our team at Raigad Hospital and Research Centre. The ideal candidate will have 1-6 years of experience in the field. Roles and Responsibility Assist surgeons during surgical procedures and ensure patient safety. Prepare and maintain operating room equipment and instruments for surgery. Monitor patient vital signs and respond to emergencies. Maintain accurate records of patient information and medical history. Collaborate with other healthcare professionals to provide comprehensive care. Participate in ongoing education and training to stay updated on latest techniques and technologies. Job Requirements Strong knowledge of medical terminology and anatomy. Ability to work effectively in a fast-paced environment and prioritize tasks. Excellent communication and interpersonal skills. Ability to maintain confidentiality and handle sensitive information. Familiarity with hospital policies and procedures. Commitment to delivering high-quality patient care and services.