14 Meddra Coding Jobs

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 activities such as literature screening, drug coding, MedDRA coding, quality review of ICSRs, and validation and submission of xEVMPD product records. Collaboration and communication are key aspects of this role, as you will work closely with data management staff, project teams, and external stakeholders to ensure the timely and accurate reporting of safety data. Your role will also involve serving as a subject matter expert in SPVG, mentoring new hires, and participating in audits/inspections as required. To be successful in this role, you should have a Bachelor's Degree in life science, nursing, pharmacy, or a related field, along with knowledge of safety database systems, medical terminology, and clinical trial processes. Proficiency in Microsoft Office Suite, excellent communication skills, attention to detail, and the ability to work both independently and collaboratively are essential. Minimal travel may be required for this position. Syneos Health is committed to providing a supportive and inclusive work environment where employees can authentically be themselves and contribute to meaningful projects that impact lives globally. Join us in our mission to accelerate customer success and make a difference in the world of biopharmaceutical solutions.,

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'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities 8 Months Contract Role Candidates from Mumbai preferrable Min 4 yrs of relevant experience required Immediate joiners preferred Assist the CSH to collect and report ADRs/AEs and other safety relevant information. . Periodic Safety Report (PSR) Management: o Local periodic reports are handled in compliance with PSPV Quality Documents (QDs/SOPs) and local regulatory PV requirements. To assist in preparing local PSRs if and when required. Contribute together with PSPV and Regulatory Affairs (RA) department to the planning for periodic safety reports. Planning, tracking and monitoring of Master Planning Table and Affiliate Tracking Table (ATT) activity. Patient Program (PP) and Managed Access Program (MAP) Management: o support PP/MAP approval with validation of documents, ensure PP/MAP vendor PV training done before PP/MAP initiation and regular refresher trainings, as and when required. Monthly review of PP/ MAP vendor QC and reconciliation activity Perform regular audit of the QC check activity performed by vendor In case of local product in-licensing or local company acquisition: Participate, in close collaboration with GPE, in the due diligence and integration process as per available Company standards. In case of local agreements with pharmaceutical companies (license-in, license-out, co-marketing-co-promotion, divestment.), a local SDEA is in place and implemented, aligned with the local regulations and Global SDEA standards and regularly revised. That global SDEAs are implemented locally when applicable. Monthly validation of agreement with PV clause/SDEA with relevant stakeholders Complete global Business plan requirements (BPPQRA activity) Maintain MyAlliance database with latest and updated documents and information. Ensure appropriate PV requirement in contracts for all types of service agreements, Purchase Orders (PO's) (where applicable), etc. Maintain schedule and conduct PV awareness, PV refresher and PV induction training, as and when required. All safety-related questions raised by local Health Authorities are collated and immediately transmitted by e-mail to the GSO of the concerned GPE Business Unit and to the relevant GPE mailbox for evaluation and organization for further immediate communication within GPE and action as relevant. Product safety alerts are handled in accordance with company product alert processes. Local PV Alerts are managed and coordinated in collaboration with GPE, the relevant medical director and local Management. Assist in management of Product Recall Develop and maintain the local Pharmacovigilance System File (LPSF) in accordance with the global standards and local legislation. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Performs safety and pharmacovigilance program delivery activities including (but not limited to) all aspects of the collection, processing, and reporting of individual cases safety reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, Medical Dictionary for Regulatory Activities (MedDRA) coding, data management activities which includes cleaning and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ISCR reports, management of duplicate ICSR cases, Quality review of ICSRs, Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) activities)) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. The processing of information may include filtering, cleaning, migrating, analyzing, reporting, filing or publication of data and information.

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, Pharmacovigilance & Regulatory sub-offerings to assist leading biopharma companies in realizing their vision and improving outcomes for patients. Your responsibilities as a Drug Safety Associate will involve solving routine problems by following general guidelines and precedents. Your interactions will primarily be within your team and with your direct supervisor. You will receive detailed to moderate levels of instruction for daily tasks and new assignments. Your decisions will impact your individual work within the focused scope of your team. Please be aware that this role may require you to work in rotational shifts. If you are looking to contribute as an individual team member in the field of Pharmacovigilance and drug safety surveillance, this position offers an opportunity to work with cutting-edge technologies and make a meaningful impact in the healthcare industry.,

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 to detail will be essential as you identify information to be queried and follow up until all queries are satisfactorily resolved. Moreover, you will be responsible for generating timely and accurate expedited reports in compliance with regulatory requirements. You will maintain safety tracking for assigned activities, perform literature screening and review for safety, drug coding, and MedDRA coding. Your role will also involve validation and submission of xEVMPD product records, management of duplicate ICSRs, activities related to SPOR/IDMP, quality review of ICSRs, and ensuring all relevant documents are submitted to the TMF and Pharmacovigilance System Master File. To excel in this position, you must maintain a thorough understanding and compliance with SOPs, global drug regulations, GCP, ICH guidelines, and project/program plans. Building constructive relationships with internal and external team members, participating in audits, and applying regulatory intelligence to safety reporting activities will be vital components of your role. Syneos Health is committed to developing its employees and providing a supportive and inclusive work environment where you can be your authentic self. Join us in our mission to accelerate customer success and make a meaningful impact on the lives of patients worldwide.,

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 responsible for fostering strong communication and relationships with clients and internal teams, providing regular updates, and proactively resolving any issues that may arise. Additionally, you will be tasked with developing project scope and objectives, planning and tracking project activities, coordinating with cross-functional resources, and ensuring the timely delivery of high-quality pharmacovigilance work. To excel in this position, you should have 3-4 years of previous experience in Pharmacovigilance Project Management, preferably in a service provider or CRO environment. A background in Life Sciences or Biomedical field with a healthcare-related degree such as pharmacology, biology, biotechnology, or veterinary science is essential. You should possess a strong skill set that includes proficiency in various PV processes and regulations, excellent client-management skills, effective communication abilities, time management skills, and attention to detail. Advanced proficiency in verbal and written English, as well as knowledge of MS Office applications, is also required for this role. Join DDReg as a Project Lead Pharmacovigilance and take advantage of this opportunity to contribute meaningfully to the field of pharmacovigilance project management while elevating your career to new heights.,

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 possess agility for quick learning, work effectively in a team setting, and demonstrate a strong commitment to quality. Proficiency in Japanese at an elementary level (JLPT N3 to N5) will be an added advantage. Your role will involve analyzing and solving lower-complexity problems, interacting with peers within Accenture, and receiving instructions on daily tasks from supervisors. While your decision-making will impact your work and potentially that of others, you will primarily focus on individual contributions within a team environment. Please be aware that this role may involve working in rotational shifts. Accenture, a global professional services company, offers expertise in digital, cloud, and security services across various industries. Within the Life Sciences R&D vertical, our services encompass research support, clinical trials, regulatory services, pharmacovigilance, and patient solutions. By joining the Clinical, Pharmacovigilance & Regulatory sub-offering, you will contribute to assisting leading biopharma companies in realizing their vision and enhancing outcomes through patient-centric approaches. Your role will be crucial in facilitating the convergence of scientific expertise with insights into the patient experience. To learn more about Accenture and our services, please visit www.accenture.com.,

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 part of the Life Sciences R&D vertical, supporting services that cover the entire life sciences landscape. From research laboratories to clinical trials support and regulatory services, your responsibilities will include pharmacovigilance and patient services solutions. You will collaborate with leading biopharma companies to bring their visions to life and enhance patient outcomes by integrating scientific expertise with insights into the patient experience. Your primary responsibilities will involve managing the Affiliate Mailbox, reconciling reports, and following up on Serious and Non-serious cases. You will be tasked with case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for Individual Case Safety Reports (ICSRs) in compliance with client guidelines and global regulatory requirements. As a Drug Safety Associate, you will be expected to solve routine problems using general guidelines and referrals, with interactions primarily within your team and direct supervisor. You will receive detailed instructions for daily tasks and new assignments, and your decisions will directly impact your work. Working as an individual contributor within a focused team, you may be required to work in rotational shifts. If you are passionate about pharmacovigilance operations, drug safety surveillance, and making a positive impact in the life sciences industry, this role at Accenture offers an exciting opportunity to contribute to cutting-edge solutions that improve patient outcomes and drive innovation.,

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 the medical review team when necessary and conduct assessments of litigation cases across assigned products. Effective communication and interaction within client therapeutic teams and functional team management are crucial aspects of this role. Additionally, you will be required to comply with applicable Global Health Authority regulations and perform other drug safety-related activities as assigned. In this position, you are expected to contribute to a team environment with professionalism and skill, demonstrating flexibility in a dynamic, fast-paced, cross-functional setting. The ability to manage multiple tasks concurrently and deliver results under stringent timelines is essential for success in this role. Educational qualifications in a relevant field, along with industry experience and specific certifications, are preferred. Key performance indicators, competencies, knowledge, skills, and abilities required for this role will be outlined to ensure your success as a Medical Safety Physician. The work environment may involve travel, and other specific requirements such as vehicle usage, work permits, contract types, time constraints, compliance-related aspects, and union affiliation will be detailed as per the company's policies and regulations.,

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: Bachelors degree in Pharmacy, Life Sciences, Nursing, or related field 2-5+ years of experience in pharmacovigilance or medical coding Hands-on experience. Familiarity with PV software. Basic understanding of ICSR and pharmacovigilance workflow. Certification in pharmacovigilance or medical coding is preferred. Interested to apply can share CV or call/WhatsApp to 9342735755

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 implement changes into the safety database. Perform quality checks and reconciliation of coded data. Support regulatory submissions by ensuring properly coded safety data. Participate in coding conventions , coding guideline development, and audit preparedness. Qualifications Bachelors degree in Life Sciences, Pharmacy, Nursing, or related field. 1-3 years of experience in drug safety coding using MedDRA Knowledge of global regulatory guidelines. Excellent communication and attention to detail. Interested to apply can share CV or call/WhatsApp to 9342735755

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.,