Specialist, Regulatory Intelligence and Analytics

Role and Responsibilities 

• Under the direction of a senior member of the team assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures trackers and templates. 
• Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes. 
• Provide internal teams and Clients with expertise and guidance on national requirements. 
• Ensure compliance with company procedures processes training records systems and any other tools 
• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables. 
• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS. 
• Provide support to proposal development and input to budgets provide department representation to BD meetings as required. 
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery. 
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required. 
• Provide feedback on performance of vendors to aid their assessment. 
• Communicate suggestions for changes to departmental/company processes/procedures and contribute to department initiatives.

Qualifications :

• Degree in Chemistry or Life Sciences Nursing or equivalent experience 
• Soft skills: Good planning and organizational skills attention to detail. interpersonal and strong communication skills 
• Basic understanding of ICH GCP across all areas 
• Previous PV/Drug Safety experience is required
• Proficiency in English both written and verbal  
• Proficiency in all MS-Office applications including Microsoft Word Excel and PowerPoint  

Additional Information :

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company possibility for your quick career growth
• Multicultural environment English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance internal trainings provided by skilled professionals but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

• Quality 
• Integrity & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look forward to welcoming your application. 

#LI Remote

Remote Work :

No

Employment Type :

Full-time