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.
The Senior PV Coordinator, QPPV office is responsible to oversee ProPharma Group’s Pharmacovigilance System Master File (PSMF) service.
Takes over the role of a Local Person responsible for Pharmacovigilance (LPPV) for ProPharma clients and serves as Subject Matter Expert (SME) for assigned PV areas.
Main responsibilities:
Maintains the controlled documents regarding the PSMF including reference documents such as the PSMF template by establishing communication with internal PSMF contributors to ensure timely, regular, as well as ad-hoc updates of the PSMF template.
Assumes the role of the PSMF coordinator and PSMF author.
Stays informed about regulatory PSMF requirements.
Reviews deviations concerning PSMF process or content to assess the potential need for updates of PSMF SOP and/or reference documents.
Assuming positions for clients for the LPPV which may include the National Contact Person (NCP) in UK.
Qualifications:
Bachelor's degree in life sciences or equivalent qualification
Good written and oral communication skills
Sound planning, prioritizing and organizational skills
Good decision making and problem-solving skills.
Attention to detail and focus on quality
Understanding and awareness of related legislation, as well as knowledge about and exposure to PV systems
Theoretical and practical knowledge in Pharmacovigilance
Good knowledge of MHRA and EU PV legislation and guidance.
The UK NCP must have at least two years of experience in Pharmacovigilance.
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ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
