Neurelis, Inc. · 1 day ago
Senior. Manager, Drug Safety & Pharmacovigilance Operations
San Diego County, CA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expNeurelis, Inc. is a rapidly growing company focused on drug safety and pharmacovigilance operations. The Sr. Manager will oversee safety-related activities for VALTOCO® and investigational compounds, ensuring compliance with regulations and managing external vendors.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Provide direction and monitor quality of contracted vendors in the collection, coding, processing of ICSRs and literature search activities involving safety information in both post-marketing and clinical trial settings
Manage Neurelis’ drug safety inbox ensuring all communications are addressed and stored in a timely and appropriate manner
Help ensure compliance with regulatory guidelines, processes and procedures and data cleanliness in preparation for audits and inspections
Participate in vendor governance activities (e.g., KPI review, quality metrics, deviation tracking)
Manage data requests and inquiries from both internal stakeholders and ex-US business partners
Assist in the creation and maintenance of Neurelis safety-related SOPs and business practices
Function as a safety contact for cross-functional departments (eg, Regulatory, Quality Assurance, MedInfo Call Center) and vendors to ensure appropriate and timely handling of safety information/issues
Help ensure compliance with processes, procedures and data cleanliness in preparation for audits and inspections
Support as a subject matter expert during internal audits and assist the Drug Safety/PV team during Agency inspection activities as required
Assist in the creation and maintenance of Neurelis safety-related SOPs and business practices
Perform other Drug Safety/PV duties as assigned
Qualification
Required
BS in life sciences/pharmacy/nursing or related field required
A minimum of 8 years' experience with a pharmaceutical or biotech company
Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
Demonstrated success with drug safety case processing combined with a thorough knowledge of drug safety systems and applications
Able to effectively manage vendors related to drug safety/pharmacovigilance operations
Prior experience in oversight and handling both expedited and non-expedited ICSRs
Excellent communication and organization skills
Strong knowledge of FDA, ICH regulatory requirements and guidelines
Strong communication and interpersonal skills
Ability to work collaboratively with cross-functional teams
Strong analytical and problem-solving skills
Ability to manage multiple projects and priorities
Demonstrates strong work ethic
Shows initiative and holds themselves accountable
Lives and advances the Neurelis culture and values
Always operates with a high degree of integrity and tact
Demonstrates sound judgment and decision-making ability
Preferred
Advanced healthcare degree preferred (i.e. MSN, Pharm.D.)
Minimum 5 years' experience in Drug Safety/PV Operations
Company
Neurelis, Inc.
Neurelis, Inc., is dedicated to innovating life-changing therapeutics that help people with neurological conditions gain greater control over their journeys.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$206.08MKey Investors
HBM Healthcare InvestmentsLYZZ Capital
2021-03-10Series D· $114M
2020-10-06Series C
2018-11-08Series Unknown· $40.5M
Leadership Team
Craig Chambliss
CEO and Co-founder
Brittany Bradrick
COO & CFO
Recent News
2026-01-12
2025-12-05
Company data provided by crunchbase