EU Pharmacovigilance PV Senior Manager – Remote, Homebased

We have an exciting opportunity available for an experienced Pharmacovigilance expert to join a rapidly growing global provider to be homebased anywhere in Europe. This is a fantastic role for a developing pharmacovigilance professional looking to work on a diverse range of pharmaceutical, biotechnology and medical device projects within a growing company with a strong potential for career growth.

Responsibilities

• Implementation of global and local PV services for clients and overseeing service delivery from operational perspective.
• Assuming positions for customers as the Local contact Person responsible for Pharmacovigilance (LPPV).
• Receipt, processing, reporting, follow-up and reconciliation of adverse event reports from any source like clinical trials, literature, post-marketing and pharmaceutical-technical complaints.
• Creation and maintenance of Pharmacovigilance System Master File, Risk Management Plans, Periodic Aggregate Safety Reports (e.g. PBRERs, PSURs, DSURs).
• Implementation and management of signal detection activities.
• (Pharmaco-)Vigilance advice on medicinal products and medical devices.
• Preparation and adherence to pharmacovigilance-relevant Standard Operating Procedures, client Working Practices and associated work instructions.
• Implementation and evaluation of global and local literature searches.
• Management of activities related to clinical trials, e.g. development of Safety Management Plans.
• Regulatory intelligence review and compliance for clients and internally.
• Prepare and negotiate Pharmacovigilance Agreements/Safety Data Exchange Agreements.
• Oversee PV Alliance Partners performing activities on behalf the company.
• Serve as Subject Matter Expert for global PV Process(es) to ensure that they are efficient, in high quality and in compliance to legislation.
• Provide PV training.
• Participate in client audits and inspections.

Qualifications

Qualified candidates must have:

• Bachelor or master’s degree in life sciences.
• Knowledge of EU and local pharmacovigilance regulations and guidelines.
• At least 3 years’ experience within the pharmacovigilance disciplines in the pharmaceutical industry, government agency or a pharmaceutical consultancy/outsource organization or equivalent experience (such as Regulatory Affairs, Medical Information etc.) within the pharmaceutical industry, government agency or a consultancy/outsource organisation would also be considered.
• Experience in review of promotional materials/ethical compliance and IMA certificate would be considered an advantage..

Following your application Simon Trebilcock, a specialist Pharmaceutical Recruiter with over 7 years’ experience recruiting in the field will discuss the opportunity with you in detail. He will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities which are also available right now or will be imminently becoming available.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0)203 928 6632.

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com