Pharmacovigilance

Pharmacovigilance

By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. The total number of adverse-event reportstotalled 60,000 across Europe, according to a report from theEuropean Medicines Agency. This figure highlights one of the key issues facing modern medicine, the need to track adverse events long after regulatory agencies have approved new drugs - enter pharmacovigilance. Typically, patients who want to report an adverse event are directed to their doctor, who can then relay that information to a pharmacovigilance data system. However, sinceonly five percent of doctorsare estimated to participate in any pharmacovigilance system, this process can be inefficient at cataloguing patient issues.

TheGerman Medicines Actprovides information obtained during the use of a medicinal product by after the marketing authorisation is granted. This is done for all finished products on the market in Germany and is the most important duty of the Pharmacovigilance Division. This Division continuously informs about the adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them. Education is the key to progress in the area of pharmacovigilance. According to a2018 report by the World Health Organization, more than 50% of all medicines are prescribed, dispensed or sold inappropriately, and 50% of patients fail to take them correctly.

A bright future is assured for employees within the sector as the global pharmacovigilance market size is estimated to grow at a CAGR of above 12.8 % over the forecast time frame 2019-2026 and reach the market value around โ‚ฌ9.5bn by 2026, according toAcumen Research.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the safety/pharmacovigilance industry in Germany and across Europe.

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Safety/Pharmacovigilance Jobs

Pharmacovigilance Data Associate

Join Our Team as a Pharmacovigilance Data Associate in Introductory Paragraph: Our client is seeking an experienced and highly-motivated individual to join their team as a Pharmacovigilance (PV) Data Associate. As the PV industry continues to grow at an unprecedented pace globally, our client recognises that data management of adverse events plays a critical role in patient safety monitoring. Key Responsibilities: - Utilise CAPA systems for case processing - Assure compliance with Good Pharmacovigilance practices - Conduct quality checks on processed cases before submission - Liaise with stakeholders such as medical information personnel Qualifications & Skills Required: -Relevant experience within pharmacovigilance or related field. -Familiarity with international regulatory requirements relating to drug safety reporting. -Sound understanding of database principles and electronic document management processes including proficiency using MedDRA coding software. -Detail-oriented approach ensuring high levels of accuracy are attained when working under pressure while maintaining strict deadlines. About The Company: Our Client operates across Europe providing pharmaceutical companies innovative solutions designed specifically support clinical development programs from phase I through post-marketing activities by supplying expert consulting services coupled together rigorous attention detail throughout all phases life cycle product development process. If you're passionate about promoting public health awareness initiatives whilst having drive succeed constantly evolving environment then we would love hear more!

Negotiable
London
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Senior Medical Director, Pharmacovigilance & Drug Safety

A growing Neurology Biotech is seeking an established leader to join their Safety team as Senior Medical Director of Pharmacovigilance and Drug Safety. This leader will assume a central role in securing our Drug Safety and Pharmacovigilance capabilities, establishing a robust Medical Safety and Risk Management team, and overseeing the safety evaluation and benefit-risk management of our products across their entire span, from initial human trials to their post-marketing phase. Your strategic awareness will be instrumental in orchestrating safety monitoring strategies within our clinical development programs, both prior to and following product launches. An unwavering commitment to uphold, and ensure adherence to, all relevant US and international legal and regulatory standards pertaining to pharmacovigilance, signal detection, and risk management is essential. The successful candidate will be at the forefront of the safety aspects for New Drug Application submissions, steering cross-functional Safety Management Teams. You will harness a culture of collaboration, liaising closely with experts across multiple disciplines, including Clinical Development, Clinical Operations and other various departments, ensuring an integrated, comprehensive approach to the company's drug safety management.

Negotiable
United States of America
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Executive Director, Medical Safety and Risk Management

This growing Neurology Biotech is seeking a seasoned and strategic leader to helm their Pharmacovigilance and Drug Safety division as an Executive Director. This pivotal role is entrusted with the stewardship of our Medical Safety and Risk Management department. This candidate will not only shape and enhance the team but also guide and nurture our adept physicians and scientists within the safety domain. You will be the authoritative voice in the safety and benefit-risk evaluations for the company's extensive product range, overseeing the entire spectrum from initial human trials to post-marketing stages. In this capacity, you are tasked with the critical mission of propelling forward our safety surveillance initiatives, forging a robust strategy for both pre-launch preparations and post-launch surveillance within our clinical development ventures. Further responsibilities include steadfastly ensuring that all operations adhere to the stringent legal and regulatory pharmacovigilance stipulations set forth by the United States and other international bodies, with a focused commitment to signal and risk management across the product portfolio. Your visionary leadership will greatly impact our New Drug Application (NDA) submissions, as you will preside over the Safety Management Teams that operate across various functions. Collaboration is key, and you will work closely with peers in Clinical Development, Operations, Pharmacology, as well as across various departments to foster a cohesive and effective drug safety environment. We are reaching out to a leader with the foresight, expertise, and dedication to drive our commitment to the highest standards of medical safety and to safeguard the health and well-being of patients worldwide through vigilance and a steadfast commitment to excellence in drug safety.

Negotiable
United States of America
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