21 Meddra Coding Jobs

Responsibilities: Thorough understanding of ICSR and/or literature monitoring processes, including all related guidelines and regulations. Provide required guidance and support, as applicable,to the Team Lead and SMEs on operational and domain aspects as necessary. Ensure tasks are assigned to the team members to meet deliverables in accordance with SLAs and KPIs. Work closely with the team and client, as applicable, to identify and mitigate risks to meet timelines, address or seek clarity for queries, if any, and escalate when necessary. Ensure that all assigned goals (e.g., utilization and efficiency) are met for self and team as set for the performance year. Conduct performance management...

Role Overview: As a Pharmacovigilance Services Specialist at Accenture, you will be responsible for performing Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports (ICSRs). Your key responsibilities will include: - Performing Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizing cases based on Regulatory clock date and seriousness criteria, ensuring timely completion as per client SOP - Reviewing all applicable Medical Review Fields for accuracy - Planning, organizing, and managing daily work to meet service level timelines and deliverables - Reviewing MedDRA coding of reported terms in Cases, suggesting additiona...

To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSR s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Causality Comment. Review and respond to any queries/comments from the Case Owner in the Safety database. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across t...

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, you will play a crucial role in ensuring the safety of patients by handling and processing Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Your responsibilities will include: - Entering information into PVG quality and tracking systems for ICSRs receipt and tracking - Assisting in processing ICSRs according to SOPs and safety plans - Triaging ICSRs, evaluating data for completeness and accuracy - Entering data into safety database, coding events, medical history, medications, and tests - Compiling complete narrative summaries and identifying information to be queried - Generating exp...

Description Safety & PV Trainee Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating...

As a Safety & PV Trainee at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. By entering information into PVG quality and tracking systems, processing ICSRs, and maintaining safety tracking, you will contribute to the accurate and timely reporting of safety data. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assisting in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triaging ICSRs, evaluating ICSR data for complet...

MBBS Doctor with experience in safety writing and signal detection. ICSR medical review/approval including MedDRA coding, listedness/expectedness,and seriousness assessment. Risk management activities such as drafting, assessment, or implementation of RM activities. Signal management activities such as drafting of qualitative and quantitative signal assessment reports. Clinical practice experience in direct patient care. Aggregate safety report drafting, review or assessment. Must have skill set MedDRA coding Aggregate report signal detection drafting PBRERs Risk Management Plans AE s Contact Person: Maheshwari Balasubramanian Email ID: maheshwari@gojobs.biz

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients participating in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, preparing project plans, processing ICSRs according to SOPs, and generating accurate reporting of expedited reports in compliance with regulatory requirements. You will be responsible for triaging ICSRs, evaluating data completeness and accuracy, entering data into safety databases, compiling narrative summaries, and assessing information to be queried. Additionally, you will participate in activit...

Description Safety PV Specialist II/ Principal PV Spl (11 months of Contract role, Mumbai) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you...

As a Pharmacovigilance Services Associate at Accenture, your role will involve supporting the Life Sciences R&D vertical by managing the Affiliate Mailbox, reconciling reports, and performing follow-up attempts for both Serious and Non-serious cases. You will be responsible for tasks such as case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database according to client guidelines and global regulatory requirements. You are expected to have a Bachelor of Pharmacy or Master of Pharmacy qualification and possess 1 to 3 years of experience in Pharmacovigilance Operations. In this position, you will work closely with the Clinical, ...

As a Safety & PV Specialist I at Syneos Health, based in the Pune Office, you will play a crucial role in ensuring the safety and pharmacovigilance of our products. Your primary responsibility will be to enter information into PVG quality and tracking systems for the receipt and tracking of ICSRs. Additionally, you will assist in the processing of ICSRs according to SOPs and project-specific safety plans. In this role, you will triage ICSRs, evaluate the data for completeness and accuracy, and ensure regulatory reportability. You will enter data into the safety database, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries. Your attention...

The Project Lead Pharmacovigilance position at DDReg offers a compelling opportunity for you to advance your career in pharmacovigilance project management. As a crucial member of the Project Management team, you will play a key role in overseeing and directing all pharmacovigilance services. Your responsibilities will include serving as the primary contact for clients, ensuring project activities align with client needs and regulatory requirements, and maintaining high-quality work standards to achieve client satisfaction. Your key accountabilities in this role will involve closely managing client relations by acting as the main liaison between clients and project teams. You will be respons...

As a Pharmacovigilance Services Analyst at Accenture, you will be responsible for providing Pharmacovigilance & Drug Safety Surveillance services. With 2 to 5 years of experience and educational qualifications in Any Graduation/Bachelor of Pharmacy/Master of Pharmacy, you will play a key role in the management of the Affiliate Mailbox, reconciliation of reports, and performing follow-up attempts for both Serious and Non-serious cases. Your responsibilities will include case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and global regulatory requirements. In this position, you are expected to po...

As a Pharmacovigilance Services Associate at Accenture, you will play a crucial role in Pharmacovigilance Operations, focusing on Drug Safety Surveillance. You should hold a Bachelor of Pharmacy or Master of Pharmacy degree and have 1 to 3 years of relevant experience. Accenture is a global professional services company known for its expertise in digital, cloud, and security solutions. With a workforce of 699,000 individuals across 120 countries, we specialize in Strategy and Consulting, Technology, and Operations services. At Accenture, we leverage technology and human ingenuity to drive value and success for our clients, shareholders, partners, and communities. In this role, you will be pa...

As a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will be responsible for reviewing and assessing individual case safety reports obtained from clinical trials, spontaneous and solicited reports. You will determine the regulatory reportability of cases within your assigned therapeutic team and across all products/sites in a timely manner. Your role will involve performing triage of cases, determining seriousness and relatedness, assigning appropriate MedDRA codes, assessing labeling, and reviewing narratives. It is essential to maintain current knowledge of the product portfolio and safety profiles across therapeutic areas. You will escalate complex case issues to ...

Roles and Responsibilities: Perform coding of Adverse Events , Medical History, Indications, and Concomitant Medications using MedDRA and WHO Drug Dictionary. Ensure accurate and consistent data entry within global safety databases. Review case narratives and source documents to assign appropriate codes. Maintain compliance with ICH, GVP, and company SOPs. Coordinate with case processors, medical reviewers, and QA teams to resolve coding discrepancies. Stay updated with MedDRA and WHO-DD version updates and apply changes. Participate in coding audits, quality control, and data consistency checks. Support safety signal detection and regulatory queries with coded data. Qualifications: Bachelor...

We are seeking a highly detail-oriented MedDRA Coder to support our Drug Safety and Pharmacovigilance operations. The ideal candidate will be responsible for the accurate and consistent coding of adverse event terms using MedDR , ensuring compliance with regulatory and quality standards. Roles and Responsibilities Code Adverse Event terms using MedDRA for clinical trials, post-marketing safety reports, and spontaneous reports. Ensure consistency and accuracy in medical terminology coding across safety databases. Collaborate with safety physicians, case processors, and medical reviewers to ensure appropriate interpretation and classification. Maintain knowledge of current MedDRA updates and i...

The Clinical Safety Reviewer (CSR) is responsible for evaluating and interpreting adverse events (AEs), serious adverse events (SAEs), and product safety data collected during clinical trials or post-marketing surveillance. The role ensures scientific and regulatory accuracy in case assessments, contributing to patient safety and regulatory compliance. Roles and Responsibilities; Review clinical safety data including ICSRs, SAEs, and narratives for accuracy and medical completeness. Assess seriousness, expectedness, and causality based on protocol, IB, and regulatory guidelines. Ensure the consistency of MedDRA coding and WHO Drug coding in line with global standards. Review and approve fina...

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Your role will also include conducting literature screening and review for safety, ...

You will be working as a Pharmacovigilance Services New Associate at Accenture, a global professional services company with expertise in digital, cloud, and security solutions across various industries. As part of the Life Sciences R&D vertical, you will support biopharma companies in enhancing patient outcomes by integrating scientific knowledge with patient insights. Your responsibilities will include managing the Affiliate Mailbox, reconciling reports, and performing follow-up activities for both Serious and Non-serious cases. You will be responsible for case identification, data entry, MedDRA coding, processing, submission, and follow-ups for ICSRs in the safety database according to cli...

As a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will be responsible for conducting review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports. You will determine the regulatory reportability of cases within assigned therapeutic team and across all products/sites in a timely manner. Your role will involve performing triage of cases, determining seriousness, relatedness, and assigning appropriate MedDRA codes. Additionally, you will review narratives, assess labeling, and escalate complex case issues to the medical review team when necessary. You must have experience with relevant safety databases and s...