Specialist, Regulatory and Pharmacovigilance Network
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Job Description
Specialist managing regulatory and pharmacovigilance deliverables for PrimeVigilance. Liaising with regulatory areas and completing PV deliverables based on established plans.
Responsibilities:
- Provide the strategy based on regulatory requirements
- Complete regulatory and PV deliverables based on an established PV and regulatory plan
- Serve as a liaison between regulatory and other functional areas
- Assume leadership and functional representation for projects of low complexity assigned
- Provide intelligence on requirements and contribute to the development of the strategy
- Support identification of issues and corrective actions
- Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
- Ensure correct training assignment to and training compliance by the LCPs
- Promptly identifying and escalating risk/potential risk to the project team
- Prepare client’s invoices and review/ approve vendors’ project invoices
- Foster professional working relationships with internal and external contacts
- Stay abreast of changing regulatory legislative requirements
- Participate in preparation for audits/inspections
Requirements:
- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
- PV training and/or working experience and other educational or professional background as required locally
- Fluent in English, both written and verbal
- Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail
Benefits:
- 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
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