Good Pharmacovigilance Practice (GVP) - Clinical Research Strong lead/solo Post Marketing Pharmacovigilance Auditing Experience PV Audits - Across the US/North America and Global as required REMS Auditing Experience Desirable - (Risk Evaluation and Mitigation Strategy)
Our growing globally connected client seeks an experienced Pharmacovigilance Auditor with solid and high level experience and knowledge of solo PV Auditing within clinical research for Vendors/Investigotors site/CRO's and REMS Auditing
My client is a leading QA Specialist organisation, with true global reach, and a growing team of successful QA professionals working across Clinical Research and Marketed products. A team of professional QA Auditing specialists, working across the full GxP QA portfolio, in collaboration with a growing portfolio of leading global life science industries.
As part of their continued growth, they now seek an experienced Pharmacovigilance Auditor to work remote home based, and undertake a variety of rewarding and challenging solo audits for multiple Clients and Vendors, including Investigator Sites / CRO's and Laboratories involved in Clinical Research, marketed products + REMS auditing.
You will already be an experienced lead/solo post marketing Pharmacovigilance Auditor, with proven clinical phase and post marketing PV auditing experience within the United States (And/Or) additionaly - international.
You will have a proven background within QA Pharmacovigilance post marketing auditing of at least 4+ years to date and will be able to demonstrate the abilities required to work independently and to manage your travel and audit follow up responsibilities.
You will demonstrate the skills required to work effectively and smart to meet deadlines and clients time criterias, and to always demonstrate a strong professional outlook to uphold the high standards and reputation of our client within industry.
Auditing experience will include at least 4+ years working within industry direct / CRO (And/Or) additional consulting to industry as a solo/lead Pharmacovigilance auditor.
Proven solo Pharmacovigilance Post Marketing and Clinical Research auditing experience, ideally to include;
> Affiliates / Business Partners / Pharmacovigilance Service Providers (Post Marketing)
> HQ leve Pharmacovigilance audits
> Also highly desirable - REMS Auditing Experience (Risk Evaluation and Mitigation Strategy)
Additional Skills / Knowledge Required:
Ideally you will have at least 3+ years experience working independently as a lead/solo PV Auditor to multiple vendors/clients located in the United States or in addition globally - Predominantly Post Marketing Pharmacovigilance
You will be fully competent in writing full and detailed PV audit reports, and will be expected to complete these for each vendor/client audit undertaken.
You will clearly demonstrate a strong work ethic to managing daily tasks and working to tight timelines, ensuring each individual client/vendor Pharmacovigilance audit project is completed to the same exemplary high levels and standards every time.
You will be available and eligible to travel locally, nationally and international if required, and be comfortable with travelling up to approx 50%
Our client, is a renowned leader within full service Quality Assurance GxPs Auditing, and seeks individuals with passion, drive and strong work ethics to complete tasks under own initiative, whilst being part of a great and successful growth team.
If you are an excellent communicator at all levels, tenacious, professional, independent, hardworking, and have a strong desire to work with an organisation that allows for a true independant and trusted consultancy feel - Then this may be your ideal next career move within Pharmacovigilance Auditing.
Our client has a broad portfolio of clients across the United States, South America, Canada, Europe, APAC and Global.
Travel - Across the US/North America. Potential global ad-hoc as required Solid knowledge of international regulatory requirements desired Ability to assimilate and analyse information rapidly Life Science Degree minimum. BSc / MSc. PharmD, PhD Current resident in the United States - Nationwide. Home Based. With eligibility to travel as required without Visa / travel restrictions Registrations, accreditations or certifications - Preferred
Our client offers a competitive salary, generous start holiday allowance, 401K, Healthcare, and provides its employed consultants the scope to develop their career, together with an exciting portfolio of clients across Pharma, Biotech and CRO's
Send your CV and support details today to : S.Felton