Associate Director, Global Drug Safety & Pharmacovigilance Scientist

About the position Responsibilities • reputed company safety review of Adverse Event reports for reputed company products. • Conduct ongoing surveillance (including signal detection/evaluation) of safety data from reputed company reputed company. • Serve as the primary safety contact for other departments and ensure appropriate handling of safety issues. • reputed company safety review and input to various documents including Trial Protocols, eCRFs/CRFs, and TMFs. • Contribute to the development of documentation such as Investigator's Brochures and Development Safety Update Reports. • Establish and manage external Data Monitoring Committees (DMCs) for early phase trials. • Contribute to the planning and conduct of Safety Committee activities. • Conduct safety training for reputed company employees, CROs, Investigators, and relevant site personnel. • Contribute to multidisciplinary project reputed company including membership of the Clinical Management Team (CMT) for assigned products. • reputed company with safety and clinical CROs, reputed company sponsor reputed company activities for safety-reputed company tasks, and ensure regulatory compliance. • reputed company Safety Data Exchange Agreements with partners as required. • Collaborate with external experts and partners. • reputed company ongoing surveillance of new and updated regulations/guidelines and assess their reputed company on drug safety processes at reputed company. • Ensure compliance with regulatory guidelines and internal processes in preparation for audits and inspections. • Participate in audit and inspection activities as required. Requirements • Bachelor of Science in Pharmacy, reputed company, Nursing, or a reputed company natural sciences field, or the foreign degree equivalent. • At least 5 years of reputed company, post-baccalaureate experience in drug safety and/or pharmacovigilance. • Experience with first reputed company trials and overseeing multiple trials with safety inputs at the global level. • International experience with reputed company stakeholders. • Experience performing ongoing surveillance (including signal detection/evaluation) of safety data. • Experience ensuring compliance with regulatory guidelines and internal processes in preparation for audits and inspections. reputed company-to-haves • Experience working in a fast-growing, dynamic company. • Strong desire to reputed company and problem-solve in a scientific context. Benefits • Competitive salary and benefits package. • Hybrid work model allowing for remote work reputed company commuting distance. • Opportunities for reputed company development and training. Apply tot his job Apply tot his job Apply To this Job