QPPV/Pharmacovigilance EU

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 QPPV and Pharmacovigilance Consultant at ProPharma Group you will be responsible for and working on multiple projects from a variety of Pharmaceutical, Biotechnology and Medical Device companies and service partner. You will lead and be accountable for a variety of Pharmacovigilance tasks, service delivery, continuous improvement, customer relationships and engagement. You will mentor and advise team members and support key Department and Organizational projects.

Essential Functions Include:

•  Accountable for the implementation of global and local PV services for clients and overseeing successful service delivery from operational perspective.
• Assuming positions for customers like the EU Qualified Person responsible for Pharmacovigilance (EU-QPPV) or the Local contact Person responsible for Pharmacovigilance (LPPV).
• As the Subject Matter Expert for key global PV Process(es), you will:
  • Create and maintain appropriate and accurate documentation.
  • Ensure that processes are efficient, high quality and in compliance to legislation.
  • Train, assess and ensure compliance.
  • Support internal and external engagement on the subject.
  • Engage in continuous improvement.
• Where required, take responsibility for and lead:
  • 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.
  • Management of activities related to clinical trials, e.g. development of Safety Management Plans.
  • Regulatory intelligence review and compliance for clients and ProPharma Group.
  • Implementation and evaluation of global and local literature searches.
• Leverages network and relationships to identify opportunities to expand service provision to existing and new clients. Leading and supporting acquisition activities including services, positioning, resourcing, pricing, and presentation.
• Take responsibility for the preparation and adherence to pharmacovigilance-relevant Standard Operating Procedures, client Working Practices and associated Work Instructions.
• Prepare and negotiate Pharmacovigilance Agreements/Safety Data Exchange Agreements.
• Identify, engage and oversee PV Alliance Partners performing activities on behalf of ProPharma Group.
• Development and delivery of PV training.
• Effectively lead 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 5 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 effective and results orientated project leadership.
• Management or Supervisory experience would be considered an advantage.
• Excellent communication and strong interpersonal skills:
  • Able to liaise and negotiate 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 and negotiate efficiently with internal departments to facilitate delivery of services.
  • Ability to influence change.
• Act as a positive and engaged role model and mentor to others.
• Strong focus on continuous improvement of processes, procedures, business activities etc. 
• Ability to proactively identify efficiencies and provide the business case for change.
• Ability to proactively identify issues or potential issues and offer solutions.
• 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.

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