Responsible for the implementation of operational tasks in the field of pharmacovigilance.

Recruiter
Cpl Resources
Employment Type
Permanent
Salary
Not disclosed
Cpl Resources logo

Associate Director Pharmacovigilance

Responsible for the implementation of operational tasks in the field of pharmacovigilance.

Leadership and coordination of projects, where company assumes an extensive drug safety responsibility on behalf of the client for medicinal products / medical devices before, during and after the marketing authorization.

High level consulting of clients and colleagues in a broad field of pharmacovigilance.

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 UpdateReports) and associated documents such as AdCOs (Addendum to the Clinical Overview), DSURs (Development Safety Update Reports), risk management plans and signal detection reports

Preparation and review of Clinical Expert Statements regarding requests from competent authorities

Writing/Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for pharmacovigilance projects

Regular monitoring and evaluation of changes in pharmacovigilance regulations

Set-up and maintenance of PV agreements of clients with their contractual partners.

QPPV/GPO

PV Auditor

Program Manager

International Service Lead

The successful candidate will have

Degree in Natural Science or equivalent and ideally also a doctorate degree

A minimum of 5 years pharmacovigilance work experience in global pharmacovigilance systems.

Knowledge of relevant legislative and non-legislative guidelines of drug safety

Detailed knowledge of project-specific SOPs (internal and customer specific) as well as the 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

For more information please contact Clodagh DArcy on or email details to