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Arbetsbeskrivning
Hays Special Recruitment are now searching for a Pharmacovigilance Lead, Nordic and Baltic.
Hays Special Recruitment are now searching for a Pharmacovigilance Lead, Nordic and Baltic for a 14-months assignment for one of our clients, with start as soon as possible. It can be placed in Denmark, Estonia, Finland, Latvia, Lithuania, Norway or Sweden.
The Pharmacovigilance Lead (PV Lead) is the primary Pharmacovigilance (PV) point of contact for the Nordics (Denmark, Finland, Norway and Sweden) and Baltics (Estonia, Latvia and Lithuania). The PV Lead is responsible for the end-to-end operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The PV Lead is a key strategic partner for the local business and provides valued consult and collaboration to all affiliate stakeholders and functions to support local objectives in alignment with the Global PV strategy and other Global Safety functions within or external to the affiliate. The PV Lead also contributes to the Global and Regional PV strategy as required.Operational Supervision of the Nordic-Baltic pharmacovigilance function.
Key Responsibilities
For Key Responsibilities, follow this link:
https://www.linkedin.com/jobs/view/2429914881/?refId=FMblNj5CQvefUSdgUPTfjA==
Essential Skills and Qualifications Required
* In-depth knowledge of Global, Regional and local PV regulations and requirements.
* Excellent written and verbal communication skills in English including.
* Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
* Excellent Project Management skills.
* Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
* Must work effectively/collaboratively in a fast-paced and matrixed environment.
* Individual must exhibit a high degree of accountability, is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize.
* Strong decision-making skills required.
* Must demonstrate initiative to effectively identify and communicate issues.
* Individual should be able to demonstrate innovative thinking.
Education and Experience Requirements for Job
* Minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
* 5+ years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Manager Level
* Experience with interacting with third parties (e.g. PV operations vendors) required
* Knowledge of Good PV Practices
* Direct experience in GxP compliant quality systems preferred
* Experience with Adverse Events Intake systems
* Experience in writing procedures, training materials and effectively delivering training to a diverse audience
* Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.
* Proficiency in English if not native language and local language
We are looking forward for your application,
Hays Specialist Recruitment