Job Title:
Medical Writer
Company:
PrimeVigilance
Location:
Global – North America, Europe, or Asia (remote or regional office-based depending on location)
Function:
Pharmacovigilance / Medical Writing
Work Pattern:
Not specified (assumed flexible/remote based on global team)
Job Description:
The Medical Writer at PrimeVigilance will be responsible for authoring and reviewing safety-related regulatory documents such as aggregate reports, Risk Management Plans (RMPs), and Periodic Benefit-Risk Evaluation Reports (PBRERs). The role includes document quality assurance, cross-functional collaboration with pharmacovigilance teams, and contribution to the continuous improvement of quality systems.
Key Accountabilities:
Author aggregate safety reports (e.g., DSURs, PBRERs), RMPs, and other safety documents throughout the product lifecycle
Perform quality control review of documents created by other Medical Writers
Stay current with medical writing best practices and pharmacovigilance requirements
Contribute to training programs and maintenance of standard operating procedures (SOPs)
Support other PV-related operations involving medical documentation
Qualifications:
PhD or MSc in Life Sciences or Healthcare (e.g., Pharmacy, Biology, Chemistry, Veterinary Medicine)
Previous experience in pharmacovigilance medical writing (PBRERs, DSURs, RMPs)
Excellent time management, organization, and multitasking abilities
Strong communication and presentation skills
Proficient in MS Office tools
Fluent in English
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