Manager, Safety Scientist (Pharmacovigilance)

TL;DR

Manager, Safety Scientist (Pharmacovigilance): Contribute to DSPV Medical Safety activities across assigned gene therapy products, including safety review, signal detection, and aggregate reporting. Focus on authoring high-quality safety reports (DSUR, PBRER, PADER), regulatory submissions, literature reviews, and inspection readiness activities.

Location: Fully remote from anywhere. Occasional domestic travel up to 10% may be expected.

Salary: $133,000–173,000 Annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Author, review, and prepare aggregate safety reports including DSUR, PBRER, PADER, SUSAR, and Line Listings to meet regulatory timelines.
• Draft and review critical documents for regulatory safety inquiries, ensuring scientific accuracy and alignment.
• Review scientific literature for safety information and appraise findings for safety reports and signal evaluations.
• Participate in safety data review, signal detection, and analysis for designated therapeutic areas.
• Oversee safety vendors and CROs, assist with case follow-up, and provide feedback from safety leads.
• Contribute to inspection readiness, clinical study reconciliation, and safety management plans.

Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, or related field.
• 5+ years in Drug Safety/Pharmacovigilance in pharmaceutical industry across investigational and marketed products.
• 4+ years with medical case reviews, aggregate reporting, safety surveillance, signal management, and risk management.
• Proven end-to-end project management in Drug Safety/PV.
• In-depth knowledge of medical terminology, GCP, ICH guidelines, global PV regulations, and drug development processes.
• Strong communication, organizational skills, and ability to handle scientific/regulatory documents.

Nice to have

• Advanced degree (Masters, PharmD, PhD), MPH, MHA, or MBA.
• Drug safety database knowledge.
• Experience in regulatory inspections.

Culture & Benefits

• Comprehensive medical, dental, vision coverage, mental health support, wellbeing reimbursement, and EAP.
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules.
• 401(k) with company match, equity awards, ESPP, company-paid life/disability insurance.
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship.
• Employee resource groups, recognition programs, volunteering opportunities.