Associate Director Pharmacovigilance-100% remote working
Our client a pharmaceutical consulting organisation are currently recruiting for an Associate Director Pharmacovigilance to join their team on a permanent basis. As Associate Director Pharmacovigilance you will be responsible for responsible for the implementation of operational tasks in the field of pharmacovigilance. Provide leadership and coordination of projects, where the organisation assumes an extensive drug safety responsibility on behalf of the client for medicinal products / medical devices.

Responsibilities

• Expert for pharmacovigilance related questions within the department as well as for customers, national and international regulatory authorities
• Set-up, management, and participation in the operative part of pharmacovigilance systems
• Evaluation of the benefit-risk profile of drugs based on current scientific knowledge - this includes the creation of safety update reports PSURs (Periodic Safety Update Reports) and associated documents such as AdCOs (Addendum to the Clinical Overview), DSURs (Development Safety Update Reports), risk management plans and signal detection reports
• Prepare and review of Clinical Expert Statements regarding requests from competent authorities
• Write/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc
• Regular monitoring and evaluation of changes in pharmacovigilance regulations
• Set-up and maintenance of PV agreements of clients with their contractual partners

• Degree in Natural Science or equivalent and ideally also a doctorate degree
• A minimum of 5 years pharmacovigilance work experience
• Knowledge of relevant legislative and non-legislative guidelines of drug safety
• Detailed knowledge of project-specific SOPs (internal and customer specific) as well as global SOPs and pharmacovigilance department-relevant SOPs
• Ability to organize operations and take over project management
• Ability to analyse and solve problems and to develop pragmatic solutions within regulatory framework
• Ability to balance client concerns and company interests
• Ability to assimilate and analyse information rapidly
• Ability to adjust rapidly to new, unknown, challenging situations
• Autonomous, concentrated and high-quality work
• Sense of responsibility
• Fluent English skills
• Excellent oral and written communication skills