Global Patient Safety Regional Liaison Manager
Karo Healthcare, Sweden

Karo is at an exciting stage in its journey to become a 1 billion European leader in consumer healthcare.

Our purpose is to deliver better everyday health through smart choices and after a series of exciting acquisitions, we now own a strong portfolio of consumer healthcare brands, including E45, Decubal, Nailner, CCS, Multi-Gyn, Flux, Paracet, Alpha Foods, Remescar and Nutravita across Global markets.

Alongside a continued active Mamp;A agenda, our target is to accelerate the growth of our current brand portfolio, growing 7-10% CAGR over the next 3 years. For our priority brands, this means double-digit growth, equating to growth well ahead of the category. To achieve this, we must serve consumers better than the competition and for Karo, this requires a transformation in how we build our brands, innovate and go to market.

Roles and responsibilities

• Act as the Coordinator of Karo Healthcare's service providers and Partners (3rdParty Local MAH) for local Pharmacovigilance and Medical Information activities
• Support and oversee Karo Healthcare's Local affiliate outside of EEA/UK activities relating to Pharmacovigilance, Medical Information and compliance and provide status reports hereof
• Support in the development of local strategic set-up, seeing synergies and selection of adequate vendors in markets outside of EEA/UK
• Lead the pre-qualification of new LPVs and initiate change of vendor if the existing vendor is not satisfactory
• Maintain and oversee of Pharmacovigilance amp; Medical Information activities locally to meet local and global regulatory requirements
• Create the communication plan for interactions with local service providers and act on that plan
• Support Global Patient Safety amp; Medical Information department in providing expertise in the local regulatory requirements impacting the PV system
• Be responsible for specific pharmacovigilance processes on a global level and drive the continuous improvement of those
• Ensure that appropriate quality and compliance measures are met with regards to local pharmacovigilance amp; medical information, and PV requirements in commercial activities
• Play a key role in ensuring a long-term and fruitful collaborations with counterparts (such as Karo Partners (3rd Party Local MAH), local service providers and affiliates outside EEA/UK)
• Ensure that Pharmacovigilance Agreements (PVAs) amp; Safety Data Exchange Agreements (SDEAs) are up-to-date and meeting the regulatory requirements
• Implementations of new product portfolios (through acquisitions or organic growth) ew or changed MAs within applicable Territory
• Local commercial and medical activities such as Market Research
• Change and updates of Regulatory documents and processes such as, but not limited to, Safety Information (RSI) such Summary of Product Characteristics (SmPC), Package Leaflet (PL) text and Safety variations
• Establish regular meetings/ communication ‘Newsletters’ with all LPVs and PV contacts at Partners (3rd Party Local MAH), including documentation of meetings and follow-up of actions to ensure Karo’s oversight globally
• Ensure appropriate PV pre-qualifications of new local vendors and Partners

Requirements

• Education Level: MSc. Pharm, Medicine, or equal master in life science
• Minimum 5 years’ experience from pharmacovigilance
• Strong coordinating amp; project management skills; previous experience as a project lead/participated in project teams
• In-depth knowledge of Pharmacovigilance (post-marketing), preferably outside of the EEA/UK, or excellent pharmacovigilance knowledge in the EEA/UK
• Advantage: Experience in regulatory affairs (medicinal products)
• Fluent in oral and written English
• Advantage: knowledge in other languages than English and Nordic languages

Personal characteristics

• Flexible mindset since it is a global environment and different time zones
• Find joy in the balance between ‘maintenance work’ and agile work
• Enjoy solving problems and mediate issues that may arise
• Structural sense and good documentation skills with ability to work towards and reach set up goals
• Good communication skills with the power to influence others
• Understand the balance between precision and getting things done
• Effective change management skills and ability to lead amp; train others
• Courageous personality that can represent the Pharmacovigilance and Medical information team positions in various environments and settings
• Show strong evidence of our Karo values

Benefits

• Opportunity to create, grow, and encourage
• Apart from a competitive salary pack, there are lots of growth opportunities to meet your person

Job Rewards and Benefits