Senior Associate, Aggregate Reporting Physician (Pharmacovigilance)

Location: Yerevan, Armenia

Company

hirify.global is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products.
• Synthesize safety information from ICSRs, aggregate analyses, clinical studies, epidemiology, literature, post-marketing surveillance, signal detection, and benefit-risk assessments.
• Draft and support PSURs, PBRERs, PADERs, DSURs, ad hoc safety reports, signal assessment reports, safety narratives, and regulatory submission sections.
• Collaborate with Safety, Medical, Regulatory, Clinical Development, Quality, and R&D stakeholders to evaluate emerging safety information.
• Support literature surveillance, safety trend interpretation, risk management activities, and evidence-based safety recommendations.
• Perform quality control reviews, ensure regulatory and SOP compliance, and support inspection and audit readiness.

Requirements

• Advanced degree required: PharmD, PhD, MD, MPH, MS, or an equivalent scientific discipline.
• 3–6 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or a related pharmaceutical, consumer health, or medical device industry.
• Knowledge of global pharmacovigilance regulations, safety reporting requirements, clinical research methodologies, epidemiology, biostatistics, and benefit-risk assessment.
• Expertise in literature evaluation, scientific data interpretation, medical writing, editing, proofreading, and document quality control.
• Strong analytical, critical-thinking, communication, presentation, project management, and organizational skills.
• Ability to work independently in a matrixed environment while managing multiple priorities and deadlines.

Culture & Benefits

• Permanent employment with flexible working hours.
• Health insurance.
• Performance and development process with end-of-year reviews.
• Continuous training and professional development.
• Team events and an end-of-year party.

Hiring process

• CV submission followed by an acknowledgement of receipt.
• Phone interview as the first step for candidates meeting the requirements.