PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

The Associate Director of Quality Management provides leadership and strategy in Quality Management in line with global strategic objectives. The Associate Director of Quality Management collaborates with global operational functions to ensure Pharmacovigilance and Medical Information activities are conducted in compliance with GVP regulations, the International Conference on Harmonization (ICH) and PrimeVigilance requirements. The Associate Director of Quality Management leads, educates, mentors and develops the Quality Management function to ensure their competence and confidence in developing skills to become subject matter experts.

Role and Responsibilities

• The Associate Director of Quality Management has a senior managerial position responsible to ensure that all Quality Management System activities are managed in compliance with regulations and company policies and in accordance with any agreements.
• The Associate Director of Quality Management leads the Quality Management function to ensure that the quality of PrimeVigilance’s Pharmacovigilance and Medical Information activities are in compliance with applicable regulatory requirements, and that its clients’ Sponsor and Marketing Authorisation Holder Obligations are fulfilled. This may include but is not limited to the following:

Deviation, non-conformities and issue management

• Supporting PrimeVigilance operational departments in assessing, reporting and addressing deviations, non-conformities and issues within timelines mandated by PrimeVigilance procedures
• Elevating serious and/or systemic issues with appropriate recommendations to Senior Leadership for immediate and long-term resolution
• Trending deviation, issue and compliance assessment data for discussion and agreement of recommendations for risk mitigation

Controlled Procedures

• Managing PrimeVigilance controlled procedures through the Quality Management Control System (QMCS)
• Maintaining oversight of the status and quality of PrimeVigilance controlled procedures

Training

• Maintaining oversight of training compliance
• Managing training relating to Quality Management responsibilities

Quality Management Control System

• Managing and maintaining the set of the system
• Providing user administration and support
• Managing and testing the Business Continuity Plan for the system

Change management of controlled systems

• Approving access to PrimeVigilance Controlled Systems

Audits and Inspections

• Supporting audits and inspections of PrimeVigilance as the Subject Matter Expert for the PrimeVigilance Quality Management System

B.Sc. in Science, Nursing, or related scientific field

All your information will be kept confidential according to EEO guidelines.

Our Offer:

• Work within a successful, highly – qualified and dynamic team
• Professional training and career development in a fast-growing healthcare company

Skills required:

• Extensive applicable pharmaceutical and/or biotech pharmacovigilance experience with a solid understanding of GVP-related Quality Management and Assurance
• GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines.
• Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
• Pharmacovigilance Development: Understands the phases, processes and techniques used to execute a Pharmacovigilance development program.
• Product Knowledge: Understands the medical/therapeutic impact of products.
• Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality management and assurance oversight
• Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions.
• Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
• Organizational skills: Must be able to prioritize work effectively to meet timelines.
• Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.