Job Title: Pharmacovigilance Medical Writer I/II
Location: Remote (Employees can work remotely)
Job Type: Full-time
Department: Medical Writing
About the Company:
PrimeVigilance, part of Ergomed PLC, is a global pharmacovigilance service provider established in 2008. With staff across Europe, North America, and Asia, the company provides specialized services in medical information, pharmacovigilance, regulatory affairs, and quality assurance. PrimeVigilance supports pharmaceutical and biotechnology partners and has become a leader in its field, covering all therapy areas, including medical devices. The company values employee well-being, providing excellent training and fostering a work-life balance.
Job Responsibilities:
Medical Writing:
Author pharmacovigilance documents including PSURs/PBRERs, PADERs, ACOs, DSURs, and RMPs
QC and review of all written output from the operations team as required
Support project managers in scheduling aggregate reports
Collaborate with the Quality, Compliance, and Training Manager to identify areas for improvement in documentation and SOPs/OGs/templates
Complete quality documentation for aggregate reports
Training and Support:
Attend kick-off meetings with new clients as required
Attend audits and inspections as necessary
Provide aggregate report training to relevant teams
Mentor and train Associate Medical Writers
Required Qualifications:
Education:
MD, pharmacy, or Life Science degree (Masters or PhD is desirable)
Experience:
Strong experience in pharmacovigilance (case processing, signal detection, or risk management), ideally within a CRO environment
Ability to manage multiple tasks and prioritize workload with attention to detail
Strong team player with effective communication skills
Skills:
Fluency in English; additional languages are a benefit
Additional Information:
PrimeVigilance is committed to diversity, equity, and inclusion, creating a workplace where people from all backgrounds can thrive.
The company offers training and career development opportunities, a supportive working environment, and the chance to work with colleagues worldwide.
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