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2 Drugsafety Jobs

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2.0 - 5.0 years

0 - 0 Lacs

hyderabad, noida, united arab emirates

On-site

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

Posted 1 day ago

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3.0 - 8.0 years

4 - 7 Lacs

Gurgaon / Gurugram, Haryana, India

On-site

Description We are seeking a highly motivated Medical Safety Physician with 3-8 years of experience to join our team. As a Medical Safety Physician, you will be responsible for ensuring patient safety and compliance with regulatory requirements. You will work closely with cross-functional teams to develop and implement safety strategies for our products. Responsibilities Develop and implement medical safety strategies for our products Manage safety-related issues and concerns from clinical trials through to post-marketing surveillance Ensure compliance with regulatory requirements and guidelines Provide medical expertise and guidance to cross-functional teams Conduct safety reviews of clinical trial protocols, study reports, and regulatory submissions Collaborate with internal and external stakeholders to assess and manage safety risks Participate in safety signal detection and assessment activities Contribute to the development and implementation of risk management plans Provide medical review of adverse event reports and ensure timely reporting to regulatory authorities Skills and Qualifications Medical degree (MBBS/MD) with 3-8 years of experience in medical safety or pharmacovigilance Knowledge of global regulatory requirements and guidelines related to drug safety Experience in safety surveillance and risk management activities Excellent analytical and problem-solving skills Ability to work independently and collaboratively in a cross-functional team environment Strong communication and interpersonal skills Attention to detail and ability to manage multiple tasks simultaneously Experience in conducting safety reviews of clinical trial protocols, study reports, and regulatory submissions

Posted 1 month ago

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