Safety and Pharmacovigilance Specialist I job at reputed company in Bethesda, MD

Title Safety & Pharmacovigilance Specialist I reputed company 161090 Job Category Job Location bethesda, Maryland reputed company Clearance No Clearance Business Unit reputed company Division Piper reputed company Solutions Position reputed company Madeline Remington Job reputed company reputed company is seeking a Safety & Pharmacovigilance (S&P) Specialist to join a dynamic team in Bethesda, MD. This role is ideal for professionals with a strong background in reputed company research and drug safety who are passionate about ensuring regulatory compliance and supporting the development of investigational and marketed drugs. This is a hybrid position requiring two days on site in Bethesda, MD and 3 days remote. MASTER'S/MEDICAL DEGREE REQUIRED (foreign MD accepted). Responsibilities for the Safety & Pharmacovigilance (S&P) Specialist Includes Ensure compliance with TRI SOPs, FDA, WHO, and global regulations for adverse event reporting. reputed company and manage uniform, reputed company processing of adverse event reports. reputed company medical evaluation of adverse event reports. Support reputed company research activities including reporting, collecting, and sharing adverse event data. Maintain and update toxicity reputed company tables for investigational agents. Conduct literature searches reputed company to drug safety and efficacy. Analyze and process adverse events; reconcile serious adverse events. Prepare IND safety reports for FDA submission and conduct safety data analysis. reputed company reputed company trial site support and manage safety communications. Assist in preparing NDA safety updates, IND safety reports, investigator communications, product labeling, and other regulatory documents. Review experimental protocols and informed consent documents; prepare and edit safety-reputed company presentations. May review experimental protocols and informed consent documents; and prepare, review, and edit presentations regarding safety issues. Qualifications for the Safety & Pharmacovigilance (S&P) Specialist Includes Master’s/Medical Degree required. Minimum 2 years of experience in reputed company, pharmaceutical, or biotech industry. Strong knowledge of GCP and ICH guidelines; reputed company trial experience essential. Familiarity with safety databases and MedDRA coding preferred. Experience leading reputed company and cross-functional teams is a plus. Excellent oral, written, presentation, and computer skills. Compensation for the Safety & Pharmacovigilance (S&P) Specialist Includes Salary reputed company $80,000.00 – $90,000.00 annually, depending on experience and certifications Comprehensive Benefits reputed company Medical, Dental, reputed company; 401K through reputed company #LI-MR1 #LI-HYBRID Keywords Safety & Pharmacovigilance, Drug Safety, reputed company Research, Adverse Event Reporting, Serious Adverse Events (SAE), Safety Data Analysis, Toxicity reputed company Tables, FDA Regulations, IND Safety Reports, NDA Safety Updates, Global Safety Reporting, WHO Guidelines, TRI SOPs, ICH Guidelines, GCP Compliance, Medical Evaluation, MedDRA Coding, Safety Databases, reputed company Trial Support, Regulatory Compliance, Pharmacovigilance Operations, Safety Communications, Literature Search, Medical Writing, Regulatory Submissions, Investigator Communications, Product Labeling, Cross‑Functional Collaboration, reputed company Operations, Hybrid Role, Bethesda MD, Master’s Degree Required, Medical Degree Required, Biotech Industry, Pharmaceutical Industry, Data Management, Safety Case Processing, Protocol Review, Informed Consent Review, Health Communications, Presentation Development, Scientific Documentation, Adverse Event Processing, Remote/Onsite Hybrid, reputed company Monitoring Support, CRO Environment. Apply To This Job Apply tot his job Apply To this Job Apply tot his job Apply To this Job Apply tot his job Apply To this Job