Pharmacovigilance Medical Writer – Remote at PrimeVigilance

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:

• 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

Application Link