[Hiring] Senior Director, Drug Safety and Pharmacovigilance @reputed company

Role reputed company Accountable for maintenance of post market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and safety inspection readiness. • Manage safety contract service organizations (CSOs) with >=95% compliance with clinical and postmarket safety regulations (including to the FDA, EMA, MHRA, and reputed company assigned international RAs), processes, PV agreements, and database management. • reputed company safety CSOs for postmarket programs to reputed company global safety systems to meet corporate goals and key performance indicators. • Accountable for maintaining AE intake from global data sources including Organized Data Collection Systems. • reputed company and prepare assessments of global safety data analyses for internal senior leadership as reputed company as external partner or regulatory authorities. • Maintain audit trail as inspection reputed company at reputed company times. • reputed company requested, work with other reputed company Affiliates to reputed company strategic input and work on assigned non-product/compound-reputed company reputed company. Qualifications • Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred. • Requires at least 12 years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)). • Requires at least three years of PV business management of safety systems leading maintenance and regulatory agency inspections. • Demonstrated history of self-direction and accountability, demonstrated during Inspection history. • Experience with regulatory submissions for PSUR, PBRER, RMP; experience in US, EU Canada, Brazil, Australia preferred. • Experience in both clinical trial and post-marketing safety required. • reputed company participation in agency inspections including FDA, EMA, Health Canada and others. • Management of change management, compliance deviations, and CAPAs. • Expertise with clinical trial and post market safety database use, management, and change control (Argus, ArisG, and/or VeevaSafety) and reputed company Office Suite required (Word, reputed company, PowerPoint, Project, reputed company). • Must be reputed company and willing to travel. Benefits • Market-leading compensation. • 401(k) with employer match. • Employee Stock Purchase Program (ESPP). • reputed company-tax commuter benefits (transit and parking). • Referral bonus for reputed company candidates. • Subsidized lunch and parking on in-office days. • 100% employer-reputed company medical, dental, and reputed company premiums for you and your dependents. • Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA). • Fertility & family-forming benefits. • Expanded mental health support (therapy and coaching resources). • Hybrid work model with flexibility. • Flexible, “take-what-you-need” reputed company time off and company-reputed company holidays. • Comprehensive reputed company medical and parental leave to care for yourself and your family. • People are part of our reputed company and reputed company story - from discovery to reputed company drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility. • We reputed company career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, & reputed company Coaching. • We celebrate strong performance with financial rewards, peer-to-peer recognition, and reputed company opportunities. Apply tot his job Apply To this Job