Pharmacovigilance Analyst
Há 3 dias
**Job Overview**
Responsible for management and service delivery excellence for assigned projects, covering single or multiple Lifecycle Safety functions mainly **post-market focused on Market Research**. Provide leadership and accountability for customer-facing activities and oversight of operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers, aligned by accounts. Collaborate with global management team and integrated partners to develop and implement initiatives/solutions to ensure Healthcare Compliance and strengthen overall engagement and ensure global Quality consistency.
**Essential Functions**
- Manage customer interface and communication for assigned projects. Represent Lifecycle Safety on Market Research projects and serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams.
- Manage Pharmacovigilance deliverables for assigned projects and bring continuity to project design and delivery through customer delivery. Tactical, day-to-day customer-facing leadership at project level. Responsibilities include quality management and compliance project management.
- Act autonomously as the Pharmacovigilance Expert and single point of contact for Governance, Executives and Integrated Partners/Suppliers.
- Provide leadership and accountability for Local Pharmacovigilance and support regional team for processing Adverse Events from Market Research. Collaborate with leadership to implement compliance initiatives and ensure global consistency.
- Manage quality for assigned projects. Help with local and global Market Research team engagement to Quality Management metrics and policies. Work closely with manager on Internal and External (by costumers ) audits, Quality Maintenance for Pharmacovigilance, Market research Compliance, etc.
- Support Market Research and Consulting business of new projects using standard operating procedures and best practices, focusing on Pharmacovigilance perspectives, ESOMAR and GDPR, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage.
- Attend meetings with internal (IQVIA cross functional project team members) and external (Customers and/or oversight group members) stakeholders. Provides project status updates, defines processes.
- Contributes during client audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans.
- Perform other duties as assigned.
**Qualifications**
- Bachelor's Degree Health science or other directly related field Req
- At least 2 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information,, Risk Management etc) Req Or
- Equivalent combination of education, training or experience Req
- Knowledge of applicable global, regional and local Pharmacovigilance regulatory requirement; i.e. Good Pharmacovigilance Practice (GPP) and IQVIA Standard Operating Procedures.
- Willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
- Strong prioritization (critical timelines), planning and organizational skills.
- Effective verbal and written communication skills including ability to work and lead teleconferences.
- Effective collaborative, organizational and delegation skills.
- Independently work on multiple projects and manage competing priorities.
- Ability to manage ambiguity.
- Strong presentation (independently present at internal/external meetings) skills; report writing skills and customer focus skills.
- Accountability, ownership and transparency.
- Creative and innovative, initiative and pro-active.
- Effective motivating, influencing and conflict resolution skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
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