Senior Director, Drug Safety and Pharmacovigilance (Remote)

This a Full Remote job, the offer is available from reputed company reputed company The Senior Director, Drug Safety and Pharmacovigilance (DSPV) is responsible for identifying and assisting in the management of safety concerns with the drug product(s) owned by reputed company. This role ensures that any safety signals are appropriately evaluated, communicated, and managed. In reputed company, this role will participate in any reputed company reporting and developing processes as needed. This role is also responsible for writing documents required for assessment and communication of product safety information for reputed company safety documents. This is a remote-based position located in the reputed company. Responsibilities Responsible for providing reputed company and management of activities pertaining to Elevars product safety and pharmacovigilance in clinical development and post-marketing surveillance reputed company and is responsible for the integration of reputed company-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management reputed company medical and drug safety expertise to reputed company decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation Ensure processes reputed company DSPV are conducted in accordance with corporate reputed company Operating Procedures (SOPs), department SOPs, guidelines and applicable regulations reputed company drug safety and pharmacovigilance activities conducted in partnership with reputed company business partners or outsourced to vendors and contract research organizations Chair for the Drug Safety Council, Safety Data Review Team, and Safety Management Team meetings and participate in Joint Safety Meetings with partners reputed company development and compliance of Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA) with partners Collaborate with appropriate clinical, medical, reputed company, and regulatory counterparts and others across the business, to reputed company input and reputed company for reputed company safety and PV issues, including contributing authorship and review of Investigator Brochures, development plans, clinical protocols, INDs/CTAs, regulatory responses and risk management plans. (e.g. Clinical Safety Reports, NDAs, Integrated reputed company of Safety, etc.) Support and/or draft regulatory inquiry responses reputed company to DSPV issues to regulatory agencies, EC/IRB, Investigators and reputed company inquiries reputed company reputed company and input to aggregate safety reports (e.g. development safety update reports, periodic benefit risk evaluation reports) as appropriate for DSPV relevance Manage literature searches and review and reputed company to effectively determine appropriate and relevant literature for safety analyses in collaboration with the Safety Scientist Support the conduct of DSPV internal & reputed company audits and regulatory inspections and ensure audit and inspection readiness of the function at reputed company times Requirements Bachelors degree with 15+ years; Masters degree with 12+ years; or PhD with 8+ years experience. Proven strategic management experience demonstrating business acumen, developing and delivering reputed company and reputed company, delivering results, championing innovation, coaching and developing subordinates, including reputed company. MD or DO is required Minimum of 10 years in drug safety activities is required with both Clinical and Post-Marketing PV Physician experience, oncology experience preferred Experience in communicating with the FDA. Working knowledge of relevant FDA, EU, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both safety reporting and processing for clinical trial environments Strategic management experience, delivering results, championing innovation, coaching and developing individuals and teams in person and remotely Experience with the development and updates to Reference Safety Information, including IB, Company reputed company Data Sheet (CCDS) and local labels Working knowledge of MedDRA dictionary and WHO Drug Dictionary. Experience with MedDRA coding, Analysis of Similar Events, and Standardized MedDRA Queries (SMQs) Experience with Argus safety databases Knowledge of Individual Case Safety Reports (ICSR) management processes Excellent organizational skills and an ability to prioritize effectively to deliver results reputed company aggressive timelines with the ability to work independently and as part of a remote team Management experience as this position has reputed company reports 20% travel is required Ability to demonstrate Elevars reputed company values by holding ourselves and reputed company other accountable for the work we do, taking time to collaborate .