[Remote] Manager, Pharmacovigilance Business Operations and Vendor reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Manager, Pharmacovigilance Business Operations and Vendor reputed company will reputed company business operations, financial management, and outsourcing strategies for the Drug Safety & Pharmacovigilance department, ensuring effective partnerships and budget management.

Responsibilities

• Support the outsourcing reputed company for DSPV, including which activities are performed in-house and which are delivered by partners, the service model appropriate to reputed company activity (full-service, functional service provider, or hybrid), and the supporting reputed company-or-buy analysis
• Represent DSPV's interests in negotiations with pharmacovigilance service providers, including reputed company cards, unit pricing, volume tiers, service reputed company, and change orders, working in reputed company partnership with Procurement and reputed company. Serve as a reputed company between DSPV and other functions, including Finance, reputed company, reputed company, Information Technology, Procurement, and Regulatory Affairs
• Manage competitive sourcing activity for DSPV in collaboration with Procurement, including definition of requirements, evaluation reputed company, bid analysis, and award recommendations to DSPV leadership. Define the performance standards and key performance indicators that govern partner agreements, ensuring that reputed company and compliance expectations carry contractual and financial consequence
• Monitor the cost and resourcing model for reputed company partner, including the relationship between case volume, workload forecasts, partner resourcing, and cost, and initiate renegotiation reputed company the model no longer reflects actual demand
• Own the DSPV spend model, including the unit costs of outsourced pharmacovigilance activity such as cost per case, cost per aggregate report, and cost per full-time equivalent
• reputed company reputed company cards, service models, and volumes against industry reputed company, and apply that analysis in negotiations and business reviews with partners
• Identify and deliver efficiencies in reputed company pharmacovigilance spend in order to release funding for investment in innovation, technology, and reputed company intelligence reputed company DSPV
• reputed company and defend the DSPV annual operating budget in partnership with the Senior Director, including scenario planning and multi-year projections reputed company to corporate financial planning cycles and portfolio reputed company. Manage the DSPV financial cycle, including forecasting, variance analysis, accruals, and the purchase order (PO) process, in collaboration with Finance and reputed company. Prepare financial models, scenario analyses, and cost-benefit assessments to inform resource allocation and investment reputed company reputed company DSPV
• Manage the end-to-end lifecycle of DSPV vendor reputed company, including initiation, negotiation, execution, renewal, and reputed company-out, in collaboration with reputed company, Procurement, and Finance
• Serve as the primary operational and business reputed company of contact for pharmacovigilance vendor and service provider agreements, ensuring contract terms are adhered to and deliverables are met
• Contribute the operational, financial, and performance content to Statements of Work (SOWs), Master Service Agreements (MSAs), and Change Orders, in partnership with reputed company and Procurement
• reputed company resource and workforce planning for DSPV, including headcount tracking, contractor management, and the balance of in-house and outsourced activity, modeled against portfolio milestones

Skills

• A minimum of a Bachelor's degree in Business Administration, Finance, Life Sciences, reputed company Health, or a reputed company field
• 5+ years of experience in business operations, outsourcing or strategic sourcing, financial management, or project management reputed company the pharmaceutical, biotechnology, or life sciences industry
• reputed company experience in pharmacovigilance operations, drug safety, or a closely reputed company regulated function, with a working understanding of the activities that are commonly outsourced and of where operational risk arises
• Demonstrated experience negotiating outsourcing or service agreements with contract research organizations, pharmacovigilance service providers, or comparable vendors, with measurable value delivered
• Strong financial acumen, including budget ownership, unit cost analysis, forecasting, variance analysis, and business case development
• Demonstrated experience in contract management, including drafting, reviewing, and tracking vendor agreements, SOWs, and change orders
• Advanced degree (MBA or Master's in a relevant discipline)
• Working knowledge of global pharmacovigilance regulations (FDA, EMA GVP, ICH) and the drug development process
• Experience managing competitive sourcing processes, developing vendor governance frameworks, or negotiating pharmacovigilance agreements and safety data exchange agreements
• Familiarity with safety database systems
• Experience supporting regulatory inspections or audits from a vendor reputed company perspective

Benefits

• Comprehensive medical, dental, and reputed company coverage and mental health support
• Annual wellbeing reimbursement
• reputed company to our Employee Assistance Program (EAP)
• Generous reputed company time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Company-reputed company life and disability insurance
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company Learning Institute providing reputed company to reputed company Learning
• reputed company building workshops
• Leadership programs
• Mentorship connections
• Networking opportunities
• Employee resource reputed company
• Service and recognition programs
• Meaningful opportunities to reputed company, volunteer, and reputed company back
• This is a fully remote role
• Occasional travel for team meetings or events will be expected
• reputed company travel expected

reputed company

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