Drug Safety Associate

Job Description

We are seeking a highly motivated and detail-oriented recent graduate to join our Drug Safety team as an Entry-Level Drug Safety Associate. This is an excellent opportunity to launch your career in the pharmaceutical industry and contribute to the safety surveillance of our products. You will gain practical experience in various aspects of drug safety, including adverse event processing, data entry, and safety reporting. This role is perfect for individuals with a strong interest in drug safety and a desire to learn and grow in a fast-paced environment. Responsibilities: Adverse Event Case Processing: Receive, triage, and accurately enter adverse event reports into the drug safety database. Ensure timely and accurate data entry in compliance with company Standard Operating Procedures (SOPs) and regulatory guidelines. Assist in the follow-up of adverse event reports to obtain complete and accurate information. Perform quality control checks on case data to ensure accuracy and consistency. Data Management and Safety Reporting: Assist in the preparation of safety reports and data summaries. Maintain accurate and organized drug safety records. Assist in the tracking and monitoring of adverse event trends. Learn to identify and escalate potential safety signals. Regulatory Compliance: Develop a basic understanding of global drug safety regulations and guidelines (e.g., ICH guidelines). Adhere to company SOPs and regulatory requirements. Assist in the preparation of regulatory submissions. General Support: Assist in the maintenance of drug safety databases and systems. Participate in team meetings and training sessions. Support senior drug safety staff as needed. Perform other duties as assigned. Qualifications: Bachelor's degree in Pharmacy, Pharmacology, Life Sciences, Nursing, or a related healthcare field. Strong interest in drug safety and pharmacovigilance. Excellent attention to detail and accuracy. Strong organizational and time-management skills. Ability to work independently and collaboratively within a team. Good communication and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Must be a recent graduate. Preferred Qualifications (but not required): Basic understanding of medical terminology. Familiarity with drug safety databases or systems. Coursework related to pharmacology or drug safety.