PV Scientist (Pharmacovigilance)

Location: On-site in Woburn, Massachusetts, United States

Salary: $137,500–$178,000 annual base pay, plus performance incentive bonus, new-hire equity, ongoing performance-based equity, and benefits.

Company

hirify.global develops oncolytic immunotherapies designed to activate durable systemic anti-tumor responses and transform cancer treatment.

What you will do

• Perform safety data analyses for Safety Management Team and Safety Committee meetings, including documentation and archiving of minutes.
• Create and maintain signal tracking processes and support safety risk identification, evaluation, and management.
• Provide pharmacovigilance expertise to Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, and contract research partners.
• Prepare health authority responses, post-marketing case queries, MedDRA and WHO Drug coding reviews, and safety database line listings.
• Prepare aggregate safety reports such as DSUR, PADER, and PSUR, coordinating inputs, database requests, content development, and quality checks.
• Plan and document literature surveillance, support BLA/MAA activities, and develop or update PV procedures, SOPs, work instructions, and risk management plans.

Requirements

• PharmD, BSN, MD, PhD, MPH, another advanced healthcare degree, or equivalent professional experience.
• At least 4 years of pharmacovigilance or research experience.
• Thorough understanding of drug development and safety surveillance activities.
• Knowledge of MedDRA terminology, clinical and safety databases, and applicable global pharmacovigilance regulations and guidelines, including CIOMS, EMA, FDA, and ICH.
• Ability to analyze, interpret, and summarize complex clinical and medical literature data with strong attention to detail and quality standards.
• Strong written and oral communication skills, self-sufficient prioritization, and proficiency with electronic systems and writing deliverables.

Culture & Benefits

• Values collaboration, boldness, commitment, and candid communication.
• Medical, dental, and vision insurance.
• 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
• Annual performance incentive bonus and equity compensation.
• On-site travel may be required for site inspections and important meetings.