Bucureşti Sectorul 1, Şos. BUCUREŞTI-PLOIEŞTI, Nr. 172-176, WILLBROOK PLATINUM BUSINESS AND CONVENTION CENTER CLADIREA B, Etaj 5
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Provide guidance, lead/co-lead projects, manages own time to meet objectives, plan resource requirements for projects across the division
Mange the development and maintenance of Country Quality Plan
Provide oversight and guidance to colleagues on review and processing of adverse event reports
Support local, internal and external safety activities in collaboration with internal and external stakeholders
Act as Business Management Subject Matter Expert for procedural documentation and training for Safety Evaluation and Reporting (SER), provide support also in identifying SER SMEs to support these tasks and collaborate with ST in managing effective rollout of processes across SER
Manage resources in the safety team depending on local organization and safety group size and conduct follow-up
Manage completion of safety-related reports to determine the safety profile of Pfizer's products and to meet regulatory requirements
Support audits, regulatory inspection and related requests, when applicable
Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country
Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and lead continuous inspection readiness efforts in collaboration with applicable headquarters inspection management teams
Review and summarize Annual Product Review and Product Quality Review (APR/PQR) reports, notify the Contractor Quality Leads (CQLs) of any issues, and provide the summary for approval
Conduct Quality oversight for base contract manufacturers and suppliers
Take a lead in change control monitoring and oversight for ESOQ teams. Monitor and support on open change controls coming due, identify change controls stalled or held. Request extension or closure of change controls in QTS
Lead and Project Manage compliance and continuous improvement initiatives and projects
Manage quality activities to support QP declaration issuance as per standard work, Dossiers Gap Assessments to support product compliance. Perform Compendial Update assessments
Support and execute tasks in the Quality Tracking System (QTS) and Supplier Management System (SMS) in support of product and contractor oversight
Review and track intercompany complaints product temperature excursions, and routine relabelling/repackaging activities. Support product compliance related activities to allow proper supply, e.g. batch Certificate of Analysis related requests
Support team in management of QTS commitments, complaints, etc. within quality systems as necessary
Provide support in management and presentations of team KPI metrics
Participate and support risk assessments related to contractors and suppliers / products as necessary
Develop and drive specific brand strategies in Romania
Develop awareness campaigns, congress content (w/ KOLs) in partnership with Medical Department
Drive execution of customer-facing strategies and tactics
Trains Field Force on product positioning and prioritization
Collaborates with Medical to educate KOLs on emergent medical research and differentiated product attributes
Allocates, executes, and maximizes in-country brand budget
Identify and exploit market-specific opportunities to grow revenue and income
Develop and execute innovative business strategies/models to maximize revenue, market share, and income growth across the designated Vaccines portfolio
Maximize revenue and IBT performance through rigorous management of the P&L and in alignment with goals
Develop and lead integrated cross-functional teams appropriate to support business priorities
Personal ownership of key stakeholder relationships
Monitor the performance of the designated portfolio and implement course-correcting actions in agreement with Marketing Lead
Conducts all activities and makes decisions that are in accordance with Company policies and SOPs, Pfizer Values, and global regulatory guidelines, as appropriate
Contribute to the completion of projects and manage own time to meet agreed targets and develop plans for activities on own projects
Develop inventory targets and budgets
Consult with and informs AMP Supply Planners of market dynamics that influence continuity of supply, both through forecast adjustments as well as through dialogue when appropriate
Responsible for ensuring Supply Assurance and Supply Chain performance of assigned portfolio of products
Represent region in global and regional forums (for assigned product portfolio)
Monitor and manage inventory shelf-life and expiry dates minimizing write-offs whilst improving processes to avoid obsolescence
Plan and implement routine launch, in-line product extensions, and major product changes enabling business unit growth
Perform root cause analysis of inventory deviations vs. targets and of inventory drivers and define improvement plans
Partner with AMP Team Lead and AMP Hub Senior Supply Planners to drive resolution of escalated issues in SCA (Supply Chain Agreement)
Exhibit strong knowledge of legislation, market practice and understanding of local Logistics market business environment
Serve as point of contact to brand supply leads and manufacturing sites for any questions related to supply issues, resolution plans, inventory for assigned set of products
Manage market forecasts in partnership with Supply Chain and related Pfizer Global Supply colleagues and functions
Ensure compliance with all relevant regulations and a state of audit readiness
Develop and maintain strategic business relationships with KOLs and other targeted HCPs in the therapeutic area of responsibility in regular visits
Initiating, planning and executing an enterprising approach to customers ensuring the expansion of product value within country
Building relationships with target customers to enhance territory/brick knowledge and gain endorsement necessary for successful promotion of product to designed customers
Identify, lead and execute any meetings/conferences/symposium/materials for our products that benefit patients - partner with team members on creation of A&P plan for the country
Ensure all activities comply with Foreign Corrupt Practices Act (FCPA) and are fully compliant with Pfizer policies - In charge for all approvals and contracts to be prepared and signed on time
Execution of ad-hoc projects, diagnosing situation in dedicated territory to design, propose and implement adjustments to territory business plan
Liaising with team members to share information and support other team members
Consolidate information from the field and present it to the management
Ensure effective implementation of designated marketing plans for market in order to achieve desired business outcomes - achieving defined targets
Act as point of first reference within the country for I&I products related enquiries and work collaboratively with colleagues in other departments (eg Regulatory, Medical, Safety, Public Affairs and other BUs)
Enable commercial customers to design and execute commercial activities embedding compliance and quality requirements through design, development, approval, execution and close-out of in-scope commercial activities (e.g. programs, tools, privacy requirements where implemented eg, IRRs for GDPR markets)
Lead in-market audit readiness activities in collaboration with Audit Readiness and Quality Oversight (ARQO) Team
Execute, manage and monitor performance of assigned CAPAs required to address issues (e.g., quality events, audit findings) in collaboration with BQ ARQO team for assigned market(s)
Upskill commercial colleagues (e.g. Program Owners) to fulfil their role during audits and inspections
Partner and collaborate across internal Biopharma Operations stakeholders including BOPs, enablement teams, and Bold Moves Team to deliver strategic solutions in support of ongoing and new business request
Contribute to the completion of projects and manage own time to meet agreed targets and develop plans for activities on own projects
Develop inventory targets and budgets
Consult with and informs AMP Supply Planners of market dynamics that influence continuity of supply, both through forecast adjustments as well as through dialogue when appropriate
Responsible for ensuring Supply Assurance and Supply Chain performance of assigned portfolio of products
Represent region in global and regional forums (for assigned product portfolio)
Monitor and manage inventory shelf-life and expiry dates minimizing write-offs whilst improving processes to avoid obsolescence
Plan and implement routine launch, in-line product extensions, and major product changes enabling business unit growth
Perform root cause analysis of inventory deviations vs. targets and of inventory drivers and define improvement plans
Partner with AMP Team Lead and AMP Hub Senior Supply Planners to drive resolution of escalated issues in SCA (Supply Chain Agreement)
Exhibit strong knowledge of legislation, market practice and understanding of local Logistics market business environment
Serve as point of contact to brand supply leads and manufacturing sites for any questions related to supply issues, resolution plans, inventory for assigned set of products
Manage market forecasts in partnership with Supply Chain and related Pfizer Global Supply colleagues and functions
Ensure compliance with all relevant regulations and a state of audit readiness
Create agendas, schedule appointments and issue meeting minutes when appropriate or as requested for meetings and conference calls
Suggest and implement process improvements for administrative tasks carried out across the department
Facilitate resolution of difficult issues and problems that arise within scope of responsibilities
Handle all duties with a high degree of integrity, professionalism and confidentiality
Organize documents and maintain an inventory of electronic and hard copy files allowing for easy access
Provide administrative/secretarial support and serve as backup administrative/secretarial support for other departments, when necessary
Manage purchase orders through Ariba system and tracking invoices
Manage set-up and logistics for large or off-site meetings
Identify, evaluate, and partner with cost-effective vendors in the execution of the activities Ensure accuracy of work and use judgment to determine work methods in different situations
Proactively and independently organize and expedite workflow and initiate follow-up, particularly when leader is offsite
Contribute ideas, fostering pace and enthusiasm, negotiating timely execution of work
Take personal accountability for quality of own work that impacts the department, manages own time, professional development, prioritize workflow