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Apply now for Pharmacovigilance Medical Writer II at PrimeVigilance. Remote role with PSUR, DSUR, RMP writing experience. October/Nov start.
PrimeVigilance, part of the Ergomed Group, is hiring a Pharmacovigilance Medical Writer II (Remote) with expertise in aggregate report writing. If you have hands-on experience in PSURs, DSURs, RMPs, and PADERs, this opportunity could accelerate your career in pharmacovigilance. The role offers flexibility, global exposure, and the chance to work with a leader in drug safety and regulatory support.
Key Responsibilities
As a Pharmacovigilance Medical Writer II, you will:
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- Prepare and review PSURs/PBRERs, PADERs, ACOs, DSURs, and RMPs.
- Perform QC and peer review of aggregate reports from the operations team.
- Support project managers in scheduling aggregate reports.
- Identify process improvements and contribute to SOP/template updates.
- Document quality compliance of aggregate reports.
- Attend client kick-off meetings, audits, and inspections as needed.
- Provide training and mentoring to Associate Medical Writers.
Required Qualifications
- MD, Pharmacy, or Life Science degree (Master’s/PhD preferred).
- Strong prior experience in pharmacovigilance aggregate report writing (case processing, signal detection, or risk management).
- Experience in a CRO environment is highly desirable.
- Ability to multitask, prioritize, and deliver with high attention to detail.
- Strong teamwork skills with mentoring ability.
- Fluency in English; additional languages are an advantage.
Why Join PrimeVigilance?
PrimeVigilance is committed to employee growth, well-being, and global collaboration. Benefits include:
- Training and internal career development.
- Supportive and inclusive work culture.
- International exposure with colleagues worldwide.
- Opportunity to contribute to improving patient safety globally.
- Work-from-home flexibility for a better work-life balance.
How to Apply
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