Company Description
For the past 20 years, ProPharma has been dedicated to enhancing patient health and wellness through expert consulting services. As the world’s largest Research Consulting Organization (RCO), we partner with biotech, medical device, and pharmaceutical companies of all sizes to advance scientific breakthroughs and introduce innovative therapies. Our comprehensive advise-build-operate model spans the entire product lifecycle, supported by our expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology. ProPharma offers fully customizable consulting solutions designed to de-risk and accelerate high-profile drug and device programs.
Job Title: Pharmacovigilance Report Author
Job Summary
We are seeking a skilled Pharmacovigilance Report Author to join our team. The role involves authoring and reviewing various aggregate reports, including PSURs, PBRERs, PADERs, Annual Reports, ACOs, and DSURs, for submission to health authorities. Additionally, the role includes drafting Risk Management Plans (RMPs), Signal Management Reports, and performing literature searches. You will be responsible for data extraction, validation, and reconciliation, supporting high-priority ad-hoc activities, and ensuring compliance with regulatory requirements. The position may also require participation in audits and inspections.
Roles & Responsibilities
Essential Functions
Necessary Skills and Abilities
Educational Requirements
Experience Requirements
Additional Information
At ProPharma, we celebrate diversity and are committed to creating an inclusive workplace where everyone can be their authentic selves. We encourage innovation, collaboration, and entrepreneurial spirit, and provide a safe environment where all employees are empowered to succeed.
Note: ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please refrain from phone calls or emails regarding this posting.
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