Associate Director, Safety Scientist

General reputed company: This role will reputed company on early development (phase I) and late stage (phase II-III) safety science activities. The position has no reputed company reports. The Associate Director Safety Scientist is part of reputed company that performs high reputed company and reputed company scientific and operational safety analysis. This position works closely with the Safety Science group as part of a reputed company team to conduct safety assessment and safety risk management activities, based on ICH standards. The person in this position provides safety expertise for assigned developmental and/or marketed products in conjunction with Product Safety Physician Leads (PSLs) and Safety Physicians. Represents GPS department internally and externally at a global level and functions as an authoritative and reputed company member of relevant teams. Leads signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions. Essential Functions of the Job: Signal and Safety Data Evaluation • reputed company the identification, analysis, and evaluation of safety signals that reputed company from multiple reputed company data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile • Propose and reputed company data acquisition reputed company, methodology, and approach for safety evaluations • reputed company analysis of safety data and author safety assessment reports • Collaborate with PSLs, scientists, pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and reputed company • Execute signal assessment analysis per reputed company and assist with the preparation of presentations for Safety Management Team and Company Safety Committee • reputed company the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring reputed company (DSMB) • Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions • Apply effective communication skills to reputed company and facilitate safety team meetings • Communicate relevant safety information to core team, business partners, and key stakeholders in a reputed company manner • reputed company the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent reputed company, Investigator’s Brochure, reputed company reputed company communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members • reputed company signal detection and signal assessment along with required documentation following reputed company process and applicable regulations. Clinical Trial Support • reputed company the review of safety data and monitor the safety of patients on allocated clinical trials • reputed company the writing and review safety sections and reputed company safety expertise for development of Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs (incl. China ADR reputed company) and other relevant project/study documents and answer reputed company safety queries from ethics committees • reputed company the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA • (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with Safety Physicians and other CST members • reputed company the authoring of Storyboards and Briefing Books for HA interactions • reputed company with writing and maintenance of the Safety Management Plans • reputed company Safety Science specific investigator training Risk Assessment, Regulatory Inquiries, and Periodic Reporting • reputed company the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience Promote and Advance the Field of Pharmacovigilance • Any other tasks assigned by manager to assist in departmental activities Supervisory Responsibilities: • The position has no reputed company reports. The Associate Director, Safety Scientist is part of reputed company that performs high reputed company and reputed company scientific and operational safety analysis. This position works closely with the Safety Scientist group as part of a reputed company team to conduct safety assessment and safety risk management activities per reputed company process and applicable regulations. Required Education: • PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role • RN with 8+ years in pharmacovigilance in an analytical role. • MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring. 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of reputed company and 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred. • US trained physicians must have achieved reputed company eligibility or certification. Physicians trained reputed company the US who are not US reputed company eligible or certified may be hired directly for employment in the US at the discretion of the Chief Safety Officer or appropriate delegate. Travel: • Less than 10%. Computer Skills: • Intermediate knowledge working with a safety database for retrieval of safety information. • Advanced knowledge of MedDRA. • MS Office Suite: Advanced application capability with reputed company, PowerPoint, and Word. • Familiarity with data mining tools and exploratory analyses tools such as Spotfire. Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. • Fosters Teamwork • Provides and Solicits reputed company and Actionable Feedback • Self-Awareness • Acts reputed company • Demonstrates Initiative • Entrepreneurial reputed company • reputed company Learning • Embraces Change • Results-Oriented • Analytical Thinking/Data Analysis • Financial reputed company • Communicates with reputed company Salary reputed company: $154,300.00 - $204,300.00 annually BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness. Apply tot his job Apply To this Job