Freelance/Contract GDP Responsible Person & LPPV

Posted 9 Days Ago
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Dublin
Senior level
Healthtech • Consulting • Pharmaceutical
The Role
The position involves acting as the Responsible Person, ensuring compliance with WDA and GDP guidelines, and supporting pharmacovigilance activities. Responsibilities include compliance oversight, guidance on promotional reviews, and advising on project success for a pharmaceutical organization.
Summary Generated by Built In

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. As the world’s largest RCO (Research Consulting Organization), 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.

Position overview 

At present we are currently supporting a Pharmaceutical organisation who require contract/freelance support across various areas of their business. At present we are looking for an experienced ‘Responsible Person’ who ideally has exposure to Pharmacovigilance activities and potentially has worked as a LPPV. This project is to commence immediately; it will run for a minimum of one year (could be up to 3) and requires around 10-12 hours per week throughout the assignment. The role can be performed largely remotely but with some travel to sites in the UK and Ireland when required. 

Responsibilities include

  • Being named and acting as the ‘Responsible Person’ for all aspects related to the WDA & GDP guidelines 

  • Ensure full compliance with all necessary guidelines in association with all RP tasks 

  • Act as the LPPV (Local Person for Pharmacovigilance) for the group 

  • Ensure all necessary guidelines and procedures are followed to ensure full compliance with the PV regulations framework 

  • Ideally provide guidance and support on Advertising and promotional review 

  • Overall support and guide the client to ensure the overall success of the project 

Qualifications

  • Must be further educated within a life-sciences discipline

  • Demonstrated experience working as a Responsible Person within the UK or Ireland is a must for WDA/GDP activities

  • Ideally you can demonstrate working as a LPPV or have a distinct background and understanding of Pharmacovigilance activities and compliance

  • Fluency in English

  • Any exposure or skills in Advertising and Promotional review would be highly sort after

  • Can perform the project as described in the job spec 

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

The Company
Bozeman, MT
2,059 Employees
On-site Workplace
Year Founded: 2001

What We Do

ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.

With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science

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