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Local Person for Pharmacovigilance, Poland (PharmaLex Company)
Tadeusza Szeligowskiego 6a, Lublin
Wygasła: 11.03.2024
full-time
umowa o pracę
home office work
manager / supervisor
Obowiązki:
The Local Person for Pharmacovigilance in Poland is responsible for the establishment and maintenance of the marketing authorisation holder’s local pharmacovigilance system, and the performance of local Pharmacovigilance Operations, such as:
Set up and manage the local pharmacovigilance system
Local Literature Search, local ICSR Management
PV Intelligence Screening, local PSMF Maintenance, local PVA Management
Setting up local Organized Data Collection
Local adaptation and submission of PSUR / RMP, local signal detection
Implementation of additional Risk Minimization Measures
Reviewing materials relating to local post-authorization safety
Integrated first Level Medical Information and PQC Support
Participate in PV-relevant audits and inspections
Provide monthly PV report on status of local PV system in the country
Social Media Strategy: Develop and implement social media strategies and campaigns aligned with the overall marketing and communication goals of the organization
Social Media Management: Manage and monitor social media channels, including scheduling and publishing posts, monitoring comments and messages, and engaging with followers
Social Media Advertising: Develop and implement paid social media advertising campaigns to promote products, services, or events. Monitor and optimize ad performance and provide regular reports on campaign results and insights
Content Creation: Create and curate high-quality, engaging, and shareable content for social media platforms, including text, images, videos, and graphics
Social Media Analytics: Monitor and analyze social media performance using analytics tools and provide insights and recommendations to improve social media strategies. Track key performance indicators (KPIs), such as engagement, reach, impressions, and conversions
Social Media Trends and Research: Stay up to date with the latest trends and best practices in social media marketing
Collaboration and Coordination: Collaborate with cross-functional teams, including marketing, PR, design, and other departments, to align social media efforts with overall marketing and communication initiatives
Brand Management: Ensure that all social media content and communications align with the brand voice, guidelines, and values of the organization. Maintain consistency in messaging, visual identity, and tone of voice across all social media platforms
Crisis Management: Act as the first point of contact for social media crises or issues and respond promptly and appropriately to address and resolve any negative feedback
Video Editor: Transform raw video footage into a finished product. Create and organize visuals, with footage but also graphics, such as transitional elements, text and subtitles, animations, or motion graphics
Pharmacovigilance, Regional Lead (PharmaLex company)
Tadeusza Szeligowskiego 6a, Lublin
Wygasła: 28.10.2023
full-time
umowa o pracę
home office work
manager / supervisor
Obowiązki:
Support on the preparation and finalization of the client Work Order
Defines and communicates agreed RASCI
Defines program staffing/re-staffing and back up staff to manage program continuity
Preparation and discussion of PSAs with Franchise / Alliance partners, consultants and PharmaLex entities
Preparation, circulation, review and finalization of the Project-specific Working Practice (WP) and customer SOPs and requirements
Defines Operational LPVS Team with clearly roles, assign responsibilities, accountabilities and work packages
Coordinate and guide LPVS Regional Leads; defines the creation and maintenance of the program documentation, including all plans, timelines and reports
Engages business entities, cross-Business Unit experts, consultants, and franchise / Alliance Partners into the Program
Principal Consultant RIM / Regulatory Data & Processes
Tadeusza Szeligowskiego 6, Lublin
Wygasła: 31.03.2023
full-time
umowa o pracę
home office work
specialist (Mid / Regular)
Obowiązki:
Accountable for ensuring we are confident in the recommendations or solution offered and that it can be delivered to scope, time, cost, and quality
Accountable for creation and maintenance of project start up documents with contributions made from across the functional PharmaLex teams e.g., User Requirement Specification
Accountable for the execution and monitoring of the delivery project plan ensuring tasks, timelines, resources, and dependencies are clearly defined and known across the client and Phlexglobal project team
Accountable for managing any risks and issues, taking ownership of minimising risk and closing out issues promptly and satisfactory relating to delivery projects
Accountable for effective project delivery to meet the client needs as per client approved documentation
Contributor to pre-sales support working with Business Development, including input into proposals and contracts
Actively participates in the Business and Systems Consulting Team, sharing and re-applying skills and knowledge and bringing in best practice
Manage documentation and Payroll System (Comarch Optima) with requests submitted by employees accordingly. Gather information on hours worked for each employee
Assist in creating and maintaining employee records and tracking contracts of employment and all associated new starter documentation
Administrate new starters and leavers, filing of employee records both paper and electronically
Ensure that confidentiality and data protection requirements are maintained and adhered to
Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements, monitor milestones and events to ensure TMF Completeness via eTMF functionality
Support development of the study-specific TMF Management Plan in collaboration with Study Team
Reviews metric report outputs with Study Teams on a recurring basis, deep dive of report outputs, identifying and sharing trends and risk areas
Provide TMF Health status updates to study team on a recurring basis, including verbal and/or written summaries
Maintain TMF Health oversight over the study lifecycle, manage remediation and retrospective reconciliation projects
Support implementation of CAPAs at study level, Identify and escalate risks and trends impacting inspection readiness
Facilitate TMF-focussed communication and collaboration between Sponsor and CROs
Act as TMF SME, including related processes, to provide ongoing support to the Study Team, support development of internal and/or external TMF-related trainings
Accountable for ensuring we deliver on our contractual promises, servicing the client effectively whilst meeting our performance targets (scope, time, cost and quality)
Accountable for execution of project schedule working with internal project team on milestones which enable successful delivery to the above performance targets
Accountable for monitoring client’s communications through structured interactions including risks and issues, taking ownership of minimising risk and closing out issues promptly and satisfactory
Accountable for co-ordination internal project team communications including management of risks and issues whilst ensuring minimal impact to client
Accountable for client governance process ensuring stakeholder’s needs are understood and met through Business as Usual and/or Strategic Effectiveness Meetings
Responsible for ongoing collection and analysis of data and feedback and turning this into strategies for continuous process improvement
Responsible for tracking financial performance against contract and active management of any over or under spend with the client whilst looping in Business Development
Continues to explore the client landscape looking for additional opportunities for services (upsells and cross sells) to be offered whilst looping in Business Development
Coaching and mentoring newer members to the Customer Success Team as competencies allow
Processing clinical trial documentation into an Electronic Trial Master File system following guidance and according to the required quality and productivity levels, across multiple clients
Identifying opportunities for process improvement
Collaborating with other process users to resolve any discrepancies and issues related to documents
Manage own sales territory of small to medium businesses and achieve annual and quarterly signings and revenue target quotas
Generate new clients through cold calling, networking, business partnerships and sales activity to promote Phlexglobal services
Develop proposals and budgets for the sales opportunities within the assigned territory and ensure that the proposals and budgets go through the appropriate review and approval process as per the Phlexglobal Sales Manual and other Phlexglobal policies
Act as client point of contact and ensure on-going client satisfaction throughout sales process and where applicable operational contract
Manage the sales process from lead generation, proposal through to contract negotiation and deal closure involving internal stakeholders as appropriate
Actively participate in all global and regional sales meetings (expected to be scheduled face-to-face one to two times per year and other virtual meetings as required)
Conduct pre-qualification of prospects for the Phlexglobal sales process
Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements, monitor milestones and events to ensure TMF Completeness via eTMF functionality
Support development of the study-specific TMF Management Plan in collaboration with Study Team
Reviews metric report outputs with Study Teams on a recurring basis, deep dive of report outputs, identifying and sharing trends and risk areas
Provide TMF Health status updates to study team on a recurring basis, including verbal and/or written summaries
Maintain TMF Health oversight over the study lifecycle, manage remediation and retrospective reconciliation projects
Support implementation of CAPAs at study level, Identify and escalate risks and trends impacting inspection readiness
Facilitate TMF-focussed communication and collaboration between Sponsor and CROs
Act as TMF SME, including related processes, to provide ongoing support to the Study Team, support development of internal and/or external TMF-related trainings
Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements, monitor milestones and events to ensure TMF Completeness via eTMF functionality
Support development of the study-specific TMF Management Plan in collaboration with Study Team
Reviews metric report outputs with Study Teams on a recurring basis, deep dive of report outputs, identifying and sharing trends and risk areas
Provide TMF Health status updates to study team on a recurring basis, including verbal and/or written summaries
Maintain TMF Health oversight over the study lifecycle, manage remediation and retrospective reconciliation projects
Support implementation of CAPAs at study level, Identify and escalate risks and trends impacting inspection readiness
Facilitate TMF-focussed communication and collaboration between Sponsor and CROs
Act as TMF SME, including related processes, to provide ongoing support to the Study Team, support development of internal and/or external TMF-related trainings
Process documents into eTMF system following guidance, process documents into eTMF system according to the required quality and productivity levels, across multiple clients
Identify opportunities for process improvement
Collaborate with other process user to resolve any discrepancies and issues related to documents