Graduated Plan Officer/Pharmacovigilance (REF8049C)

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

As Pharmacovigilance Consultant at ProPharma Group you will be working on projects from a variety of Pharmaceutical, Biotechnology and Medical Device companies. You will be responsible for a variety of Pharmacovigilance tasks, service delivery, continuous improvement, customer relationships and engagement.

Essential Functions Include:

• Implementation of global and local PV services for clients and overseeing service delivery from operational perspective.
• Assuming positions for customers like the Local contact Person responsible for Pharmacovigilance (LPPV) which will include the Graduated Plan Officer in Germany or the UK national contact person.
• 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 ProPharma Group.
• Prepare and negotiate Pharmacovigilance Agreements/Safety Data Exchange Agreements.
• Oversee PV Alliance Partners performing activities on behalf of ProPharma Group.
• 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.

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.
• Good communication and strong interpersonal skills:
• Able to liaise efficiently with client companies to ensure the client needs are met.
• Able to work within a team in an open and professional manner.
• Able to liaise efficiently with internal departments to facilitate delivery of services.
• Sound planning, prioritizing and organizational skills.
• Excellent written and oral communication skills and computer literacy.
• High level of accuracy and attention to detail.
• Proactive and positive approach.
• Ability to manage multiple projects.
• Ability to anticipate issues and offer solutions.

• All candidates must be legally eligible to work in Germany.
• ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***