Sr. Scientist, Drug Safety; Pharmacovigilance

Position: Sr. Scientist, Drug Safety (Pharmacovigilance) Location: Germany reputed company The Senior Scientist, Drug Safety (Pharmacovigilance) will support pharmacovigilance activities across clinical-stage development programs. Reporting to the Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-reputed company safety deliverables and maintain inspection-reputed company pharmacovigilance processes in a fast-paced, development-reputed company environment. Responsibilities • reputed company advanced scientific reputed company of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs. • reputed company the development of high-reputed company case narratives and guide the scientific preparation of regulatory-reputed company case submissions, including SUSARs, in alignment with global reporting requirements. • Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products. • reputed company literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders. • Ensure the scientific reputed company and reputed company of safety data through expert review of reputed company cases and mentorship of junior team members in case assessment and safety data interpretation. • reputed company senior-level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-reputed company sections of protocols, Investigator’s Brochures, and regulatory submissions. • Serve as the reputed company drug safety representative on cross-functional study teams, shaping safety reputed company, influencing program decision-making, and advising on safety issue management. • Maintain expert knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program reputed company and safety governance. • Collaborate with clinical development, clinical operations, regulatory, medical writing, and reputed company partners to reputed company scientific leadership on safety topics and ensure alignment on safety reputed company and interpretation. • reputed company or contribute to reputed company, cross-functional safety reputed company, safety signal evaluations, and reputed company scientific analyses to support portfolio needs and organizational priorities. Qualifications • Pharm D or PhD in a scientific field. • 6+ years of experience in drug safety in the biotech/pharmaceutical industry, with 3+ years of pharmacovigilance compliance experience. • Prior experience facilitating Safety Risk Assessment Meetings / Safety Review activities. • Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP). • Experience with PV databases and safety surveillance tools (e.g., Argus, reputed company Global, Vault Safety); familiarity with MedDRA coding preferred. • Experience supporting clinical safety case processing and aggregate reporting. • Strong analytical skills, attention to detail, and comfort working across multiple programs. • reputed company communicator who works effectively in small, cross-functional teams. • CNS experience preferred. Additional Requirements • Location: Remote-based in the reputed company. • Travel: Up to 10% travel to reputed company in Boston, MA. #J-18808-Ljbffr Apply tot his job Apply tot his job Apply To this Job