IQVIA Associate Quality Management Director in Buenos Aires, Argentina
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Internal Job Description
The Associate Quality Management Director, Lifecycle Safety, is responsible for quality and deviation management across global Lifecycle Safety functions including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting. The Associate Quality Management Director will partner with Lifecycle Safety functional specialists and/or management to assess quality trends, processes and procedures for continued improvement opportunities including CAPA management.
The Associate Quality Management Director will support Lifecycle Safety Functions with preparation, training for audits and inspection, attendance and support during those audits and inspections and will provide guidance for CAPA owners to timely resolution. The Associate Quality Management Director may also act as QM lead for our Lifecycle Safety clients accounts.
Adopt and implement the Global Quality Management Plan within the scope of the assignment; this will include
planning and executing the Quality Management activities;
risk identification and assessment through proactive risk assessment.
Deviation management through CAPA resolution
Quality issue management through CAPA resolution
Providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
Liaises closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery.
Contribute to the development and implementation of a Regional/Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
Provide advice and support to functional operational teams within the Lifecycle Safety Department including ICSR case processing, Regulatory reporting, Medical Information, endpoint adjudication and aggregate reporting
Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
Inform Heads of Quality Management, Heads of the assigned business line and Quality Assurance of quality issues according to SOPs.
Work closely with Quality Assurance and assigned business staff in case of suspected misconduct; as required by the applicable SOPs.
Provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with the Head of QM and as required by the applicable SOPs.
Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment -, attend meetings/teleconferences.
Prepare periodic reports to Heads of Quality Management and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
Upon agreement with the Head of Quality/Operational Management:o May serve as Lead QM for a project or programo Perform any other reasonable tasks as required by the role.
If job holder is delegated as Line Manager:o Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include: planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
Knowledge of National and International Regulations and Drug Development processes
Knowledge of CRO or Pharmaceutical industry operations
Knowledge of Quintiles corporate standards and SOPs
Good organizational, interpersonal and communication skills
Good judgement and decision-making skills
Strong influencing and negotiation skills
Strong computer skills including Microsoft Office and Clinical Trial Management System (CTMS) applications
Demonstrated ability to work in a matrix environment
Excellent problem-solving skills
Ability to travel within the region/country
Ability to lead and motivate a clinical team
Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 7 years’ experience in Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc). Preferably with 2 of these years being in a related Quality position.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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