Professional Summary
Dedicated and detail-oriented Drug Safety Associate with 3 years of experience in the pharmaceutical industry. Skilled in creating and maintaining pharmacovigilance systems and ensuring compliance with regulatory requirements.
Excellent analytical and communication skills which drive successful team outcomes and high-quality results.
Experience
Drug Safety Associate
ABC Pharma Corp, Bridgewater, NJ
February 2019 - Present
- Responsible for performing the creation of therapeutic area, signal detection and management of adverse event cases for marketed drugs, in collaboration with the leads of the Medical Safety Evaluation (MSE) team
- Perform coding of adverse events using MedDRA, manual causality assessments, and completeness assessments of Individual Case Safety Reports (ICSRs) and Aggregate Reports (ARs)
- Support the preparation of safety notifications for submission to health authorities, including review of clinical study reports and summary documents as needed.
- Completed signal detection and data mining in safety databases to identify safety signals, trends and patterns of adverse drug reactions (ADRs) and mediates the review, analysis, and interpretation of relevant data to support documentation of safety assessments
- Contribute to the preparation of Risk Evaluation and Mitigation Strategies (REMS) documents
Drug Safety/Pharmacovigilance Intern
XYZ Pharma Corp, Princeton, NJ
May 2017 - August 2017
- Performed data entry and completion of case narrative sections for clinical trial Adverse Event reports, and safety surveillance reports entering data into safety database (Argus) management system.
- Assisted in the collection and review of pertinent information, preparation, review of Periodic Adverse Drug Experience Reports (PADER) and periodical safety update reports (PSUR)
- Conducted adverse event classification using Medical Dictionary for Regulatory Activities (MedDRA)
- Assisted in literature search, review, and consolidation of relevant safety data from published articles for safety files.
Education
Introduction:
If you're interested in the field of drug safety and seeking a role as a Drug Safety Associate, then you'll need a powerful resume that highlights your experience and skills. The Drug Safety Associate's role is critical in ensuring the safety of medication and protecting patient's lives.
Essential Tips for Writing a Drug Safety Associate Resume:
- Begin with a well-structured and clear resume layout. You may use bullet points and different sections to organize your information and make it easy for hiring managers to scan your resume.
- Mention your education in the field of pharmacology or a related discipline. Make sure to list any relevant certifications or training courses that demonstrate your expertise in drug safety.
- Highlight your experience working with drug development, clinical research, or other relevant experience in the pharmaceutical industry. Emphasize your experience with developing and monitoring drug safety procedures.
- Show your knowledge of key regulations and guidelines relevant to drug safety, such as FDA guidelines and good clinical practices.
- Showcase your analytical and problem-solving skills by describing how you have identified and resolved drug safety issues. Be sure to emphasize your ability to work in a team environment and collaborate with cross-functional teams.
- Include any experience you might have working with drug safety databases, including Oracle Argus and other drug safety systems, to manage adverse event reporting and documentation.
- Consider including any experience you may have working with electronic health records (EHRs) in your resume since this is becoming a popular technology within the healthcare sector.
- Show your attention to detail and know-how to manage complex projects with deadlines and high stakes. Be specific with your accomplishments and results through your use of metrics and data when possible.
Conclusion:
Writing a Drug Safety Associate resume requires highlighting your experience, expertise, and skills in the pharmaceutical industry. When creating your resume, focus on showing how you're well-versed in drug safety guidelines, regulations, and procedures. Use a well-organized format and bullet points to highlight your relevant experience and qualifications. With the right resume, you can land the job as a Drug Safety Associate and make your mark on the pharmaceutical industry.
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