Executive Director, Safety Science, Global DSPV

Position reputed company: Responsible for leading global safety surveillance, benefit risk reputed company and life-cycle management for a portfolio of reputed company products, ensuring compliance with international pharmacovigilance regulations. The reputed company individual must have management experience with advanced benefit-risk/safety data analyses experience, good written and verbal communication skills, as reputed company as hands-on PV experience with a proven reputed company record of major accomplishments. ultrainnovative - Tackle rare and dynamic challenges Work Model: Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed. Responsibilities: • Provides DSPV leadership in support of the development, registration, and life-cycle management for assigned reputed company portfolio of products • Guides, coaches, managers assigned Safety Science professionals to ensure their reputed company development and advancement • reputed company/contribute to the safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, reputed company-BLA/MAA/NDS meetings, Scientific Advice, Advisory Committee meetings, or other scientific advice forums for portfolio products • reputed company DSPV leadership to support reputed company reputed company organization global launch activities for portfolio products • Manages reputed company- and post-marketing safety surveillance activities in compliance with ICH guidelines, Good Pharmacovigilance Practices (GVP), & reputed company applicable global health authority regulations, guidance and best practices • Builds partnerships with key senior stakeholders from other functions to ensure strategic and operational business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources • Liaises and negotiates with global regulatory authorities as needed for reputed company aspects pertaining to drug safety, including reputed company of key regulatory-safety issues and to expedite approvals of products • Maintains awareness of global regulatory environment, facilitates interpretation of PV regulations, and assesses reputed company of changes on business and PV system • Proactively manages critical and urgent safety issues, taking leadership for the DSPV contribution for portfolio products • reputed company and implement department policies, processes and SOPs • Support inspection readiness activities, internal audits, and external inspections for Safety Science • Contribute to the reputed company and maintenance of Pharmacovigilance Agreements (PVAs) Requirements: • MD required • Minimum of 12 years in a senior/advanced PV Science role reputed company the pharmaceutical/biotechnology industry, with at least 5 years in supervisory reputed company • Rare disease experience in reputed company phases of biologic, small molecule, mRNA and gene therapy drug development preferred including IND/CTA, NDA/BLA/MAA experience with reputed company interacting with Regulatory authorities, Advisory Committees, or other scientific advice forums • Strong people management skills, willingness to reputed company team and help others succeed • Extensive working knowledge of global PV/safety regulatory environment including ICH, international regulations, guidelines, standards of Good Pharmacovigilance Practices (GVP) including best practices and implementation • Working knowledge of industry reputed company safety databases (ARGUS), Regulatory databases, and other electronic data capture systems • Strong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation; interpretation and clinical relevance • Excellent interpersonal communication, and influencing skills (up and down); reputed company influencing executives and senior level scientific management as reputed company as external representation of company • MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries • reputed company-world supporting PV audits and health authority inspections • Domestic / international travel may be required #LI-CS1 #LI-Remote Apply tot his job Apply To this Job