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Regulatory Intelligence Specialist, Pharmacovigilance and Analytics Expert
hace 2 meses
Job Summary
PrimeVigilance, a mid-size pharmacovigilance service provider, has an exciting opportunity for a Senior Associate, Regulatory Intelligence and Analytics. As a key member of our team, you will be responsible for delivering high-quality regulatory intelligence and analytics to support our clients' success in the pharmaceutical and biotechnology industries.
About the Role
The successful candidate will have a strong background in regulatory affairs, pharmacovigilance, and analytics, with excellent planning and organizational skills. You will be responsible for providing regulatory intelligence and analytics support to our clients, including the development of regulatory strategies, the screening of regulatory legislative requirements, and the maintenance of the regulatory intelligence database.
Key Responsibilities
Data Analysis and Reporting:
• Conduct regular screening of regulatory legislative requirements and ensure timely dissemination of pertinent changes to internal teams.
• Provide administrative support to BD activities, including the preparation of marketing materials and the coordination of client meetings.
Regulatory Compliance:
• Ensure compliance with company procedures, processes, training records, systems, and any other tools.
• Provide guidance on national requirements to internal teams and ensure that clients are aware of regulatory changes.
Project Management:
• Manage multiple projects simultaneously, prioritizing tasks and ensuring timely completion of deliverables.
• Identify and escalate potential risks to the project team, ensuring that clients are informed of any changes or delays.
Communication:
• Foster professional working relationships with internal and external contacts at the local and international levels.
• Provide clear and concise information to internal teams and clients, ensuring that they are informed of regulatory changes and requirements.
Qualifications
• Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.
• Previous regulatory experience within the pharmaceutical/CRO industry.
• Excellent planning and organizational skills.
• Good written and verbal communication skills.
• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment.
About Us
PrimeVigilance is a specialized mid-size pharmacovigilance service provider established in 2008. We have achieved global organic growth year after year, with staff based across Europe, North America, and Asia. We are proud to have a diverse and inclusive workplace culture, where employees can contribute and grow.
Ergomed Group
We are part of the Ergomed Group, a leading provider of clinical development and pharmacovigilance services to the pharmaceutical and biotechnology industries. Our group has a strong commitment to quality, integrity, and trust, and we believe in investing in our staff to ensure their growth and development.
What We Offer
• Training and career development opportunities.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues based all over the world, with English as the company language.
Core Values
At Ergomed Group, we believe in the importance of our core values, which are key to how we operate. These values include quality, integrity & trust, drive & passion, agility & responsiveness, and belonging. We believe in creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.
Join Our Team
We look forward to welcoming your application and becoming part of our global team. Please submit your CV and a cover letter to [insert contact information].
