Medical Valley/Xiromed is a fast-growing Generic Company focused on tender markets in North Europe. The aim is to deliver savings in older pharmaceutical therapies, allowing states and insurance systems to allocate more resources to newer, more efficient and costlier therapies leading to a sustainable healthcare system in North Europe.

Medical Valley/Xiromed with HQ in Höllviken is operating in 9 countries in north EU selling approx 75 different products in different therapeutic areas. Although it is an independent company it is owned by a larger developing and manufacturing pharmaceutical company, INSUD Pharma based in Spain.

For more information about the company and the products, see Medical Valley homepage https://http://www.insudpharma.com/ or http://www.medicalvalley.se/

 

Pharmacovigilance Manager - Deputy EU QPPV


Profile
Medical Valley/Xiromed wants to advance its in-house management of pharmacovigilance activities and is therefore seeking a new team member to perform a wide range of processes related to the post-marketing safety surveillance of our products on the European market. You will work in close collaboration with the EU QPPV, QA, RA and our international European team and business partners.

You will take the role as deputy EU QPPV and report directly to the CEO.


Key responsibilities

• Assist with the execution of the pharmacovigilance operations in accordance with the European PV legislation
• Maintain and lead changes of our global pharmacovigilance system
• Resume the responsibility of EU QPPV when delegated
• Ensure management of the PSMF, Risk Management Plans/instructions and SOPs for post approval safety surveillance
• Maintain an overview of the product portfolio, our business partners/CROs and ensure tasks in the company are performed in accordance with current routines, methods, SOPs and current legal requirements
• Ensure coaching and PV training of the Medical Valley/Xiromed organization
• Participate in pharmacovigilance audits/inspections
• Act as contact person to CROs, business partners, health authorities and our international team


Qualifications

Our preferred candidate has the following qualifications:
• You have a life sciences/pharmacy/nursing degree with proven analytical skills and understanding of scientific methodology
• 3 or more years of experience with post-marketing pharmacovigilance
• You have experience of management of a QA/PV system
• You pay attention to details and have experience with the most commonly used IT platforms
• You can communicate effectively being fluent in written and spoken English
• You enjoy working independently with multiple tasks in a customer and team-oriented environment


Personal characteristics / Required skills

• Enjoy working in the fast-paced environment of a growing company, where the working process is in continuous development and the portfolio is growing fast
• Capability to work effectively, at times under pressure
• Ability to set clearly defined objectives, take the lead to manage your tasks effectively with high quality and work in an organised way
• Have integrity and perspective to balance sometimes conflicting interests, quickly finding the best solution moving forward for the maximum benefit of the company
• Demonstrates a rapid understanding of newly presented information, gathers comprehensive information to support decision making
• Entrepreneurial mind set and innovate, produces new ideas, approaches or insights
• Adapts to changing circumstances, accepts new ideas and change initiatives


What we offer / Opportunities with the role

You will be key part of a multifunctional and international team. You will have the opportunity to travel and build relations across this innovative and entrepreneurial organization. The fast growth of the company offers great opportunities for personal development. We have a flat organization with room for individual ownership and for progressing your work in an innovative direction

For more information about the company and the products, see Medical Valley homepage
https://http://www.insudpharma.com/ or http://www.medicalvalley.se/  


Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.

E:
catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E:
eva.runnerstrom@peaksearch.se
M: +46 701 725 379


Application

Apply for the position at
http://www.peaksearch.se