London, UK

Associate VP of Pharmacovigilance & Quality

London, UK

Salary: Competitive + Benefits + Bonus

If you are a senior-level quality and pharmacovigilance professional and Qualified Person in releasing Human Medicinal Products, then we want to hear from you!

Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As Associate VP of PV & QA you will be responsible for executing the company’s QA and PV strategy, driving safety and compliance for all GXP and GVP activities globally. Reporting to the COO, with a dotted reporting line to the CEO, you will be a member of the executive team that sets the overall strategic direction of the company.

In this role you will provide the leadership in ensuring that there is a quality-led culture across the organisation embedded into everything that we do, fit for both short- and long-term goals, including:

  • Ensuring that Quality supports all major projects where quality is an integral part of the outcome to success
  • Leadership of the Quality and PV functions, including the definition and implementation of the respective strategies for the business and translation into function goals and objectives
  • Ensuring that the Quality & PV functions have the resources and organisational structure to deliver the short-term annual goals, whilst ensuring that the longer-term activities are planned well in advance, by working closely with the wider organisation growth plans and for any environmental regulatory policy changes
  • Ensuring a robust QMS and PV system is in place and maintaining performance in line with EU GMP and GVP standards and, where appropriate, other GXP standards globally
  • Implementing continuous improvement of Quality & PV processes to ensure robustness and resilience to changes and focusing on preventive rather than just corrective
  • Providing visibility of QMS & PV system metrics to the Executive team, and provide leadership to ensure maintenance and continuous improvement in both systems
  • Accountability for the Quality & PV oversight of External Business Partners, Vendor management and compliance, due diligence and on-boarding – including development, implementation and maintenance of risk-based audit schedule
  • Leading Inspection Readiness efforts and maintain Self-Inspection programmes for Quality & PV
  • Accountability for oversight of and collaboration with Internal Business Partners, PD, Technical, Regulatory, Commercial and Supply Chain
  • Ensuring the appropriate communication strategies are setup with local Health Authorities, including timely communication on Quality issues
  • Accountability for product batch release
  • Accountability for the Pharmaceutical Quality System, eQMS, APQR, stability, complaints, recall, deviations, GMP computer systems
  • Leading collaboration with key stakeholders internally in Regulatory, Product Development, Technical, Supply Chain and PMO to ensure strategy is implemented in a compliant manner with Quality and PV principles at the centre
  • Leading the management of the PV function including setup of a structure which allows for robust management of outsourced PV provider
  • Accountability for the co-ordination and oversight of the pharmacovigilance system including of case management activities for post marketed products and managing the day-to-day activities of the global Pharmacovigilance operations.
  • Responsibility for establishing and maintaining a network of local PV representatives across territories for the existing portfolio and new acquisitions.
  • Overseeing the delivery of internal procedures PV training to Pharmanovia employees to ensure compliance with PV regulations and Global Safety policies/procedures
  • Ensuring maintenance of processes and compliance with PV regulations and guidance, including oversight of key PV documentation such as PSMF, PVMP and SPS

About you:

You will have a proven track record of successfully managing teams in Quality, Pharmacovigilance and Medical Affairs within the pharmaceutical industry, with a pragmatic approach and commitment to quality, patient safety and achieving the best outcome. Candidates who have 15 years’ experience are likely to have the right level of knowledge and have gained the right level of experience needed to be able to undertake this role.

You should also ideally have:

  • Degree in Chemistry, Biology or Pharmaceutical Science
  • Postgraduate Degree in Pharmaceutical Studies or equivalent is desirable
  • Eligibility to be added as a QP to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use
  • Membership of the Royal Pharmaceutical Society, Royal Society of Chemistry or Royal Society of Biology
  • API Auditing and/or GMP or GVP Auditing certification with accompanying experience and strong expertise of GMP and GVP regulations
  • Proven experience of supporting manufacture and packaging of solid dosage forms, liquids, creams and sterile products
  • Ability to drive performance and accountabilities through clear SMART goal setting
  • Proven experience of supporting Regulatory Inspections
  • Previous experience within Quality Assurance, creating policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA etc.
  • Excellent working knowledge of current EU Guide to GMP
  • Good working knowledge of Risk Management
  • Knowledge and experience with relevant industry guidelines, Quality & PV processes and regulations
  • Strong decision-making, time management and organisational skills
  • Self-starter, determined, culturally versatile, entrepreneurial and results-driven
  • Professional gravitas and strong influencing and negotiating skills, with personal and professional maturity and the ability to work at a strategic/leadership level
  • Ability to see and set the big picture and strategy, with a hands-on approach
  • Developed problem-solving skills, analytical and detail oriented
  • Ability to stay calm, logical and focused on priorities whilst addressing / coordinating several issues
  • An enjoyment of getting involved in the business at all levels and across all disciplines and working with global functional in a matrix organisation
  • Excellent communication skills both written and oral with the ability to forge good working relationships with internal and external customers

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.

Apply now and become part of our team

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