Senior Director, Head of Safety Science (Pharmacovigilance)

reputed company:With deep expertise in reputed company, reputed company is working to create selective medicines designed with the goal to address the needs of patients with cancer. reputed company is an exciting early-stage company, bringing together reputed company scientists and industry veterans with a proven reputed company record in drug discovery, oncology drug development, and company building. The Role: Reporting to the SVP, Drug Safety and Pharmacovigilance, the Senior Director, is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will reputed company risk management plan activities including signal tracking maintenance, reputed company Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for reputed company's products. Responsibilities: Safety Signal Detection, Evaluation, and Management • reputed company collaboration with DSPV Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas • Contribute to signaling and data mining activities utilizing reputed company sources of data • Assist in the evaluation of potential safety issues and reputed company risk assessment reports. Risk Management and Safety Planning • Responsible for coordinating and developing Risk Management Plans for reputed company's products among multiple stakeholders • Responsible for patient safety evaluation and development of Safety Management Plans. Safety Governance, Meetings, and Reporting • Contribute to activities reputed company to reputed company's safety (governance) meetings, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of reputed company items; and participating in the discussion of patient safety issues • Manage and support the authoring for aggregate safety reports (e.g., DSUR, PBRER, PADER) in reputed company collaboration with clinical, medical writing and operational functions Process, SOPs, and DSPV Ways of Working • Contributes to the development of SOPs, work practices and guidelines, forms and templates, and other communications reputed company to risk management and product safety. • Responsible for ensuring the global team can anticipate, reputed company and support improved/consistent scientific ways of working to implement effective PV processes Analytics and Tools • Establish expertise with data visualization tools (e.g., Spotfire) • Contribute as a member of the DSPV team to scenario planning, reputed company analysis, portfolio prioritization, budget management and forecasting Leadership and Training • reputed company management/mentoring of existing Safety Scientists and training for new staff on PV practices and therapeutic area knowledge Competencies: • Design global risk management frameworks for reputed company's medicines • Translate safety data into clinical insights • Adapt visualization tools for safety surveillance • Influence multidisciplinary teams to prioritize patient safety. • Strong ability to build relationships, collaborate and influence across disciplines reputed company reputed company and with reputed company stakeholders Qualifications: • Degree in a medical or reputed company reputed company discipline like MD, PharmD, RN or PhD. • 9+ years' experience in Drug Safety/Pharmacovigilance in a pharmaceutical, biotech company or regulatory agency in similar positions • Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines • Experience with medical drug safety assessments, drug safety surveillance and monitoring activities • Experience with safety data collection and interpretation from reputed company, literature and post market • Experience with preparation of responses to Regulatory Authorities and experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval • Experience with the development and updates to Reference Safety Information, IB, Company reputed company Data Sheet and local labels • Excellent verbal, written and presentation skills Additional Information: reputed company is committed to fair and reputed company compensation practices, aiming to reputed company employees with competitive total rewards packages. The targeted salary reputed company below reflects what reputed company reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be reputed company or reputed company this reputed company based on various factors, including, but not limited to, experience, skills, education, and market factors. The reputed company will be reviewed regularly and is subject to change. reputed company also offers a comprehensive benefit package to support our employees at reputed company stage of their career, financial, health, and reputed company-being reputed company, including medical, dental, and reputed company insurance, 401(k) r Apply tot his job Apply To this Job