Freelance/Contract Pharmacovigilance Consultant - PV QA/Auditing

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We are currently supporting a leading Biological client as they require Pharmacovigilance support on an operational and strategic basis. This project will support activities in PV Quality Assurance; PV auditing and Risk management activities while also working with other projects as and when required. Currently we are looking to partner with an experienced PV professional (independent Consultant) who has the availability to start immediately for a 6 month period on a full time basis. The project can be performed largely remotely but with 1x trip to the Benelux region throughout the 6 month period.

Key responsibilities

• Actively conduct PV audits across the group which includes all follow up activities

• Ensure full compliance with all necessary regulations globally

• Support any ongoing inspections when requested

• Support and lead deviations and CAPA activities

• Perform Risk assessments as and when requirement

• Support Risk management activities

• Provide overall guidance and support for our client's Pharmacovigilance activities

Experience required

• Educated to a BSc level or higher within a life-sciences discipline

• Highly experience within the Pharmacovigilance area

• Proven skills working on PV QA, PV auditing and supporting Risk management activities is preferred

• Thorough understanding of the Regulations within the Pharmacovigilance area

• Able to support projects both operationally and strategically

• Fluency in English is a must

• Must currently reside in the UK or EU

• Can perform the project to the required level as specified in the job description

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