4 Meddra Coding Jobs

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 final case versions for submission to regulatory authorities. Collaborate with medical writers, PV associates, and biostatisticians on aggregate report contributions. Participate in signal detection and risk assessment meetings (as required). Ensure compliance with global pharmacovigilance regulations (e.g., ICH E2E, GVP). Eligibility / Qualifications: MBBS / BDS / BPharm / PharmD / MPharm / BHMS / BAMS with relevant PV training. Minimum1- 4 years experience in pharmacovigilance or clinical safety (mandatory for mid-level). Strong understanding of clinical trial protocols, GCP, MedDRA, and WHO-DD. Hands-on experience with PV databases like Argus , ARISg , or equivalent. Interested to apply can share you CV in Whatsapp/Call to 9342735755

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, maintaining drug dictionaries, and ensuring compliance with global drug regulations, Good Clinical Practice (GCP), and ICH guidelines. You will collaborate with internal and external stakeholders to generate expedited safety reports, participate in audits, and apply regulatory intelligence to safety reporting activities. At Syneos Health, we are committed to fostering a culture of diversity and inclusion where every individual feels valued and respected. You will have the opportunity to develop your skills through career advancement opportunities, supportive management, and comprehensive training programs. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. To excel in this role, you should have a strong attention to detail, the ability to work effectively in a team environment, and a commitment to maintaining high standards of quality and compliance. Your contributions will be instrumental in supporting clinical trials and post-marketing programs, ensuring the safety and well-being of patients and enhancing the overall success of our organization. If you are passionate about making a meaningful impact in the field of biopharmaceutical solutions and are eager to collaborate with like-minded professionals, we invite you to explore the exciting opportunities available at Syneos Health. Join us in our mission to transform lives and drive innovation in healthcare. For more information about Syneos Health and our global impact, please visit our website at http://www.syneoshealth.com.,

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 client guidelines and global regulatory requirements. In this role, you will solve routine problems based on guidelines and precedents, primarily interacting with your team and supervisor. You will receive detailed instructions for your tasks, and your decisions will be closely supervised, impacting your own work within a predetermined scope. Please note that rotational shifts may be required for this position. Qualifications required for this role include a BSc or Bachelor of Pharmacy degree, with proficiency in English (International). Ideally, you should have 0 to 1 years of experience in Pharmacovigilance Operations, focusing on Pharmacovigilance & Drug Safety Surveillance.,

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 software applications, along with proven customer handling and relationship skills. Task management and people management capabilities are essential for this role. Your presentation skills will be put to use as you communicate effectively within and across client therapeutic teams. It is important to have knowledge of the Life Sciences Industry, drug life cycles, and relevant product and industry information. In this position, you will acquire and maintain current knowledge of product portfolios and safety profiles across therapeutic areas. You will be responsible for identifying and resolving case issues, coordinating with client therapeutic teams, and adhering to applicable Global Health Authority regulations. Moreover, you may be required to contribute to a team environment, demonstrate flexibility, and complete multiple tasks concurrently under stringent timelines. The ideal candidate for this role should possess a relevant educational background, required certifications, and industry experience. Key performance indicators, competencies, knowledge, skills, and abilities play a crucial role in ensuring success in this position. Understanding work environment details, specific requirements, and other job-related information will be essential for carrying out the responsibilities effectively. In summary, as a Medical Safety Physician at Qinecsa Solutions India Private Limited, you will play a vital role in ensuring the safety and regulatory compliance of products across therapeutic areas while effectively managing case reviews, communication with clients, and maintaining knowledge of industry regulations and standards.,