Senior Lead, Pv Science And Operations, Wch

Biogen

Remote
$198,000.00-$272,000.00; bonus/equity: cash bonus ...
Remote
Global safety operations oversight
Pharmacovigilance vendor management
Cross-functional safety governance leadership
Biogen is seeking a Senior Pharmacovigilance Lead for its West Coast Hub, responsible for providing strategic and operational safety support for development programs. This remote position involves managing internal and external resources, overseeing safety governance, and ensuring compliance with global safety regulations. ###

Job Summary

  • Provide strategic and operational PV/safety support for West Coast Hub development programs, overseeing global safety operations and ensuring high-quality pharmacovigilance deliverables.
  • Manage internal and external PV resources, lead cross-functional safety governance, and serve as a subject matter expert for safety strategy across clinical development, regulatory filings, and post-marketing activities.
  • The role is integral to the business structure, fostering collaboration and advancing the strategic safety objectives of the organization.

Matching Summary

Match Score: 85

Biogen is seeking a Senior Pharmacovigilance Lead for its West Coast Hub, responsible for providing strategic and operational safety support for development programs. This remote position involves managing internal and external resources, overseeing safety governance, and ensuring compliance with global safety regulations. ###

Salary

$198,000.00-$272,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Fitness, Disability, Paid Time Off, 401(k), ESPP, Tuition Reimbursement

Skills & Requirements

Must-have

  • Global safety operations oversight
  • Pharmacovigilance vendor management
  • Cross-functional safety governance leadership
  • Adverse event assessment and reporting
  • Safety Management Plan development

Nice-to-have

  • Continuous improvement initiatives
  • Inspection readiness
  • Strategic benefit-risk assessments

Key Requirements

  • Bachelor's degree with 10+ years of industry experience
  • Minimum 8 years focused on clinical/safety and demonstrated PV expertise
  • Professional health background (RN, PharmD, MD) highly preferred
  • Knowledge of global safety regulations and MedDRA terminology
  • Experience reviewing cumulative safety data and authoring safety reports

Work Rights

Not specified

Tailored Resume

Cover Letter