Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

Position Purpose

• Lead/support the management of deviations within the QMS process for WSR including qualification and/or triage of significant quality events within WSR.

• Provide support to Quality Event/CAPA and Commitment Leads/Owners and serve as conduit between BPOs, business lines, quality groups and governance groups to enable and promote quality, accountability and effective delivery of CAPAs and Commitments across WSR.

• Support Inspections and audits as appropriate

​Organizational Relationship(s) including to whom the position reports (JD Job Title):

Reports to Head of Pharmacovigilance Quality Oversight

Primary Responsibilities

• Lead/support the management of quality events within WSR as per processes described in QMS 01
• Assess all Quality events received within WSR as described in QMS 01
• Ensure appropriate assignment of all CAPAs associated to PV activities by SRQ including identification of appropriate business line lead and business line quality group lead in consultation with business process owners.
• Provide appropriate mentorship of business line quality leads to support CAPA management and documentation
• Perform Quality Checks on WSR CAPAs to ensure completeness and inspection readiness
• Provide support to CAPA and Commitment Leads/Owners and serves as conduit between BPOs, business lines, quality groups and governance groups to enable and promote quality, accountability and effective delivery of CAPAs and Commitments
• Act as the SRQ partner to facilitate progress and close CAPAs and commitments arising from regulatory inspections and internal audits, as appropriate.
• Develop and facilitate mechanisms/processes for monitoring of quality system performance and effectiveness (e.g. effectiveness of CAPAs, proactive identification of quality issues) across the Pharmacovigilance QMS in collaboration with governance bodies
• Develop/support processes for trending and collating inspection and audit commitments in support of the Quality system
• Participate in/facilitate continuous improvement processes to optimize the PV quality system and keep it current, based on applicable worldwide regulations.
• Provide inspection and audit support as appropriate.

Qualifications (i.e., preferred education, experience, attributes)

Technical Skill Requirements:

• Strategic Thinking – Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions.

• Clinical, Regulatory and Safety Expertise - Demonstrated knowledge of clinical research processes, safety or regulatory requirements.

• Technical Expertise – Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.

• Organizational Development – Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.

• Project and Process Management & Meeting Established Deadlines – Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines. Demonstrated ability to adapt to changing situations and work well under pressure.

• Presentation/Influencing/Organizational Skills - Strong platform skills evident.

• Ability to lead by example and effectively implement strategies through influence and persuasion.

• Multitasking – Demonstrated ability to effectively work on simultaneous complex projects/deliverables.

• Team and Matrix Structure – Ability to work effectively and contribute proactively in a team-based environment as well as in partnership with colleagues, customers, and stakeholders.

• Analytical and Statistical Skills – Demonstrated analytical and statistical skills, knowledge of root cause analysis techniques

• Systems Technologies – Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, PowerPoint, Visio, etc.). and CAPA tracking tools.

Education:  

• Candidates for this job should have a degree in a scientific or technical discipline with the following levels of education/experience:

• B.S. Degree (or equivalent) with commensurate experience in inspections, audits, quality and compliance.

Experience:

• 1-2 years minimum experience focusing on Pharmacovigilance, Regulatory Affairs, Quality Management, CAPA management or within a Health Authority.

• Extensive knowledge of the pharmaceutical industry including Pharmacovigilance and ICH compliance regulations and guidelines and expertise within the pharmacovigilance, inspection, audit, or quality and compliance arena

• Demonstrated awareness of the key differences in how business is practiced in various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship with internal and external partners and effectively represent Pfizer as a multinational organization.

• Experience in collaborating or interacting with health authorities (including but not limited to the US FDA, EMA, MHRA) or with other global regulators is highly desired

• Demonstrated awareness of the key differences in how business is practiced in various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship with internal and external partners and effectively represent Pfizer as a multinational organization.

 
Work Location Assignment: Flexible