Associate Director / Manager, Pharmacovigilance QA (Quality Assurance)
The purpose of this role is to provide PV Quality Assurance within GSK R&D, by (1) providing input into the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program across GSK R&D, (2) Identifying compliance issues, monitoring trends and (3) being accountable for driving quality improvements back into Global Safety and improve PVQA processes.
The successful applicant will lead holistic QA activities by supporting the business, being involved in PV regulatory inspections and building solid working relationships with Global Safety stakeholders to build network of contacts while maintaining knowledge of local regulatory frameworks and global regulatory reporting requirements. In this role you will
Closing Date for Applications: 28th August 2022 (COB)
- Assist in the development, management, and implementation of strategies and initiatives, policies and procedures to support the PV audit program
- Develop, implement and assess PV quality assurance strategies, organizational and operational needs.
- Independently manage comprehensive PV/MV quality assurance programs and assess adherence to quality standards and compliance with PV/MV, International regulations and Guidelines, and GSK policies and procedures. Independently plan, lead, and conduct routine and complex audits of PV activities within Global Safety, LOCs, External Service Providers and Licensing Partners to assure compliance with PV regulations, GSK policies and procedure, and applicable local regulations.
- Be responsible for primary internal customer base including Global Safety, LOCs, Safety Governance, Risk Management, QPPVs, GRA
- Lead PV consultancy efforts with Business Units and / or regions, as appropriate
- Pro-actively perform as a risk-management consultant, providing expert advice in relation to obtaining compliance, quality improvement, holistic quality initiatives, and risk assessment
- Collaborate with Global Safety staff to interpret international regulations and guidelines and establish and monitor compliance for acceptable standards for PV/MV activities
- Be responsible for training and providing feedback to peers
- Act as inspection coordinator for PV related regulatory authority inspections of GSK
- Generate and provide metrics, status and periodic reports and other information to identify trends and develop improvements across the business
- Act as a consultant and represent PVQA to central and local safety teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment
- Provide expert advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment, and act as point of contact for customers and CQA staff for PVQA
- Maintain an up-to-date and in-depth knowledge of appropriate national and international PV/GCP legislation and guidelines that affect the business
- Maintain an in-depth knowledge of PV processes and procedures
- Develop and maintain a network of contacts with other quality and compliance groups as well as client areas
- Educate, guide and influence GSK management and staff on best quality and compliance practices, especially as they relate to areas of identified responsibility
- Build and maintain beneficial working relationships with all internal and external customers
- Support the recruitment of new PVQA staff
- Develop PV training program to PVQA advisors
- Interact with regulatory agencies in designated region(s) as appropriate or as needed
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
*LI-GSK Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in related Life Science, Pharmacy, or related discipline. Equivalent experience will be considered
- A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and drug safety
- Good Pharmacovigilance Practice Compliance, Good Clinical Practice Compliance and/or Quality Assurance, Drug Development experience
- Expert knowledge of global, regional and national PV regulatory requirements and regulations
- Detailed knowledge of the drug/clinical development processes and R&D Systems
- Detailed knowledge of pre and post marketing PV/MV activities associated with different areas of the business (e.g., clinical trials, manufacturing, regulatory affairs, commercial, toxicology)
- Proven ability to influence and negotiate with key internal and external stakeholders
- Ability to deliver key process improvement initiatives
- Ability and desire for frequent domestic and international travel (approximately 25-40%)
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members
- Ability to work independently and make decisions with minimal supervision
- Must have a high degree of organizational awareness and working towards resolution with complex problems
- Have demonstrated project management skills and management of complex cross-functional activities
- Have demonstrated ability for good verbal, written and presentation skills
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