Associate Director, Drug Safety and Pharmacovigilance Scientist

This a Full Remote job, the offer is available from: Massachusetts (USA) 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 Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including reputed company, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to reputed company interpretation and summaries of drug safety information and reputed company input in the reputed company of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be an reputed company part of a group of safety professionals reputed company reputed company and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and reputed company knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. Responsibilities: • Contribute to the reputed company of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and reputed company medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports • Contribute to signaling and safety surveillance processes, including the identification of safety observations, reputed company safety concerns and new safety signals, ensure reputed company assessment and communication of confirmed safety signals • Serve as a medical resource for the reputed company and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information • Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents • Contribute to the development of reputed company Operating Procedures, Working Instructions and other guidance documents • reputed company safety and pharmacovigilance training programs as required • Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input • Support the medical assessment of ICSRs as needed • Support other pharmacovigilance and drug safety responsibilities as assigned Competencies Include: • 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: • 4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency • Degree in a medical or reputed company reputed company discipline like MD, PharmD, RN or PhD. • 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 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) retirement savings plan, generous reputed company time off (including a summer and winter reputed company Apply tot his job Apply To this Job