About Company At Career.aliyucares, we're building a future where patient safety is paramount, driving innovation in healthcare. For a dedicated Drug Safety Analyst, this means an unparalleled opportunity to impact lives globally, working with cutting-edge pharmacovigilance technologies. We champion a culture of meticulous attention to detail, continuous learning, and collaborative problem-solving. Join a team where your expertise is not just valued but crucial, contributing directly to ensuring the safe and effective use of pharmaceutical products. Our remote-first approach provides flexibility, allowing you to thrive professionally while balancing personal well-being.

Job Description

Career.aliyucares is seeking a highly motivated and detail-oriented Drug Safety Analyst to join our dynamic and fully remote team. This pivotal role offers an exciting opportunity to contribute significantly to global patient safety by meticulously monitoring, evaluating, and reporting adverse events associated with pharmaceutical products. As a Drug Safety Analyst, you will be instrumental in maintaining compliance with international pharmacovigilance regulations, ensuring the integrity and accuracy of safety data, and supporting the overall drug development lifecycle. In this remote capacity, you will leverage your expertise to perform comprehensive case processing, including data entry, narrative writing, and MedDRA coding for individual case safety reports (ICSRs). You will be responsible for the timely submission of these reports to regulatory authorities worldwide, adhering to strict timelines and quality standards. The ideal candidate possesses a robust understanding of drug safety principles, medical terminology, and regulatory requirements (e.g., FDA, EMA, ICH guidelines). Your ability to critically assess medical information, identify safety signals, and communicate complex data clearly will be paramount to your success. This role requires a proactive approach to problem-solving and a commitment to continuous improvement. You will collaborate closely with cross-functional teams, including medical monitors, clinical operations, and regulatory affairs, to ensure a cohesive approach to patient safety. We value individuals who are not only proficient in their technical skills but also possess strong ethical judgment and a deep sense of responsibility. If you are passionate about safeguarding public health from the comfort of your home office, thrive in an independent yet supportive environment, and are eager to make a tangible difference in the pharmaceutical industry, we encourage you to apply. Join Career.aliyucares and be part of a mission-driven organization dedicated to excellence in pharmacovigilance.

Key Responsibilities

• Process and review individual case safety reports (ICSRs) from various sources, ensuring accuracy, completeness, and adherence to regulatory requirements.
• Perform medical coding of adverse events and medical history using MedDRA and concomitant medications using WHO Drug dictionary.
• Write comprehensive case narratives summarizing all relevant clinical and safety information.
• Identify and escalate potential safety signals to the appropriate teams for further evaluation.
• Ensure timely and accurate submission of ICSRs to regulatory authorities worldwide.
• Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Participate in quality control checks and data reconciliation activities.
• Collaborate with medical monitors, clinical operations, and regulatory affairs teams on safety-related matters.
• Assist in the preparation of aggregate safety reports and other safety documents as required.
• Contribute to the development and improvement of pharmacovigilance processes and procedures. Required Skills
• Minimum of 2-3 years of experience in pharmacovigilance or drug safety.
• Strong understanding of medical terminology, disease processes, and pharmaceutical products.
• Proficiency in MedDRA and WHO Drug coding.
• Excellent written and verbal communication skills.
• Demonstrated ability to work independently and manage multiple tasks in a remote environment.
• Meticulous attention to detail and strong organizational skills.
• Proficiency with pharmacovigilance databases (e.g., Argus, ArisG) and Microsoft Office Suite.
• Ability to critically analyze and interpret complex medical data.
• Knowledge of global pharmacovigilance regulations (e.g., ICH, FDA, EMA).

Preferred Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Experience with different therapeutic areas.
• Certification in Pharmacovigilance or Drug Safety.
• Familiarity with signal detection processes and tools.
• Experience in a CRO or pharmaceutical company setting. Perks & Benefits
• Competitive salary and comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• 401(k) matching program.
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