Associate, Regulatory Intelligence and Analytics
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
- Provide intelligence on requirements and contribute to the development of the strategy and set up activities including Regulatory Management Plan joint operating procedures POAs and core documents. Support identification of issues.
- Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
- Provide internal teams with 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 administrative support to BD activities.
- 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.
Qualifications :
- Degree in Chemistry or Life Sciences Nursing or equivalent experience
- Previous experience within the pharmaceutical/CRO industry not required however preferred
- Good planning and organizational skills
- Good written and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills in a fast-paced deadline oriented and changing environment
- Good attention to detail
- Excellent self-motivation skills
- Proficiency in English both written and verbal
- Proficiency in all MS-Office applications including Microsoft Word Excel and PowerPoint
Additional Information :
Why PrimeVigilance
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.
The roll offers:
- Diverse tasks - data mining screenings analysis requirements review.
- Chance to build a broad and comprehensive knowledge on PhV processes and requirements
- Chance to expand knowledge on other areas covered by Regulatory department i.e. clinical trials marketing authorisations XEVMPD PV Network
- A role in development of RI processes in a motivating environment
- Training and career development opportunities internally
- 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
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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Adobe Analytics
- Data Analytics
- SQL
- Attribution Modeling
- Power BI
- R
- Regression Analysis
- Data Visualization
- Tableau
- Data Mining
- SAS
- Analytics
About Company
Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more
