13 Oct
Ortolan
London
Job description
Director of Pharmacovigilance & Compliance
This is a full-time permanent position - we are also willing to consider a contractor who can commit to a 6-12 months FTC Immediate start for contractor.
Basildon / London, UK - Hybrid working
3 days office based, 2 days work from home)
Salary : Competitive + Benefits + Bonus
If you are an experienced pharmacovigilance professional with extensive knowledge of EU-GVP, US-FDA & other global PV requirements, 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 160 markets.
Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
Our core behaviours are :
- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- We value our heritage and foster an entrepreneurial spirit.
- We reinvest in our future - in our products, our brands, and our people.
- We give back to our communities.
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 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.
A.E., India, Singapore,
Italy, Spain, and South Korea.
We are an agile, committed, and innovative 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 :
Your primary responsibility as of the Head of Pharmacovigilance & Compliance will be to take ownership of the PV operations of the business.
Working closely with the senior leadership team you will provide direction for the organisation ensuring that both compliance and company objectives are met.
As subject matter expert and PoC for all safety related matters within the organisation you'll be responsible for ensuring patient safety & regulatory compliance is always maintained.
You'll also be tasked with developing the PV system & compliance for the business and take on responsibility for the oversight and performance of global and local PV vendors (sourcing & performance).
Part of this role will be responsible for the compliance management of the wider PV & Quality management system, particularly concerning licence partners, ensuring continued compliance and improvements as required.
The role :
The role will report directly to the associate vice president of Quality & Pharmacovigilance. This leadership role also has direct & indirect line management responsibility.
Main responsibilities :
- Acting as head of department and accountable for all activities related to PV globally.
- Development of in-house processes / procedures ensuring compliance to global legislative requirements.
- Compliance across the PV / Quality system and oversight of local licence partners.
- Performing trend analysis, RCAs and oversight of corrective measures to continuously develop and improve performance & compliance of established systems.
- Tracking and management and resolution of identified compliance issues.
- Monitoring, tracking, and reporting on partner performance to wider business groups for oversight,
escalations etc.
- Oversight of Pharmanovia quality and compliance systems and utilisation of KPIs and automation tools to deliver sustained and improved compliance across the organisation.
- Oversight & accountable for the oversight of key PV vendor activities, processes to ensure appropriate performance.
- Set-up of local PV systems and processes / agreements with local partners.
- Ensuring that the PV system is compliant and the quality management system is maintained.
- Oversight of quality related areas of the PV system e.g. PV audits, CAPAs, deviations.
- Identification & negotiation of contracts with vendors to manage local PV activities.
- Development of in-house processes to support key PV internal activities.
- Increasing awareness of PV system, process & department across the organisation.
- Leadership & oversight of Due Diligence activities from a PV perspective.
- Leading recruitment activities of wider team.
- Leading / supporting during internal / external PV audits & inspections.
- Being a point of contact within Pharmanovia for routine internal projects, acting as a PV stakeholder cross functionally.
- Supporting PV risk assessment & Due Diligence activities as required.
- Monitoring and maintaining PV compliance across all key workstreams, ensuring appropriate measures are put in place.
- Management of wider PV function globally.
- Responsible for wider strategic and functional direction and represent PV within the organisation.
- Driving organisational & cultural change towards a more compliant PV system.
- Leading projects for digital and AI initiatives to improve efficiency within the PV system.
- Development, tracking, management and reporting of KPIs to senior leadership team.
- Interaction with cross functional leadership colleagues and senior management to ensure adequate oversight and supporting wider business goals / objectives.
- Leading / hosting PV audits & inspections.
- Direct line management of PV function and indirect management of key stakeholders at PV vendor.
- Responsible for the management of the PV budget.
About you :
Key skills required are extensive knowledge of EU-GVP, US-FDA & other global PV requirements, confident communicator both within the business and external partners,
previous line management experience, driven and motivated to build and develop systems / processes.
- MD, PharmD or qualification in a related scientific field.
- Extensive experience in pharmaceutical drug safety and pharmacovigilance compliance.
- Experience in supporting regulatory authority inspections.
- Experience gained within a Medicines Agency and / or a Medicines Regulatory Authority would be advantageous.
- Managerial / functional management or lead experience preferred.
- Extensive experience within Pharmacovigilance and Patient Safety.
- Experience in quality related areas of the PV system e.g. PV audits, CAPAs, deviations.
- Strong knowledge of International pharmacovigilance regulatory requirements.
- In-depth knowledge of drug development process, safety monitoring, and risk / benefit analysis.
- Experience with the writing / reviewing of safety documents and reports.
- Ability to evaluate, interpret and synthesize scientific data.
- Team player with ability to work cross-functionally in a highly agile environment.
What we offer :
This is a hybrid working role - 3 days office based, 2 days' work from home. Applicants will be required to work at least 1 of the 3 office days each week in our UK HO in Basildon.
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.
▶️ Director of Pharmacovigilance & Compliance
🖊️ Ortolan
📍 London