Job Summary/Objective: 

The Sr. Manager, Drug Safety & Pharmacovigilance Operations will be responsible for managing 

safety and PV related activities involving VALTOCO® (diazepam nasal spray) and Neurelis’ 

suite of investigational compounds. This role will support the supervision of external pharmacovigilance vendors regarding the collection, processing and reconciliation of drug safety information and ensure these operations are conducted in compliance with applicable regulations, guidelines and standards. This person will support the development of periodic safety reports to meet our regulatory submission obligations, participate in cross-departmental discussions on reportable events (AEs/PCs), and function as a drug safety/PV contact for both internal colleagues and external stakeholders. 

This position requires a subject matter expert who can focus on tactical execution, provide 

direction on process improvements and contribute to the strategic buildout of the department. 

The Sr. Manager, Drug Safety & PV Operations will participate in the maintenance of the Global Safety Database and help develop global drug safety reporting procedures to ensure compliance with regional adverse event reporting requirements. As a part of our team, this role will function as a high-impact contributor within a small and rapidly growing company.

Essential Job Functions:

• 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.

Competency (Knowledge, Skills, and Abilities):

• 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.

Personal Performance Factors:

• 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. 

Management Responsibilities and Skills:

• No direct reports. 

Physical Demands and Work Environment: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Spends approximately 90% of work time sitting and meeting with others or working at a desk and/or computer. Spends approximately 10% of work time standing or walking within the work area or at meetings and bends, twists, stoops and reaches. Ability to communicate verbally and in writing. Occasionally lifts and/or moves up to 10 pounds. Working conditions are normal for an office environment. The noise level is usually moderate. 

Travel Requirements:

• Ability to travel up to 15% to attend medical and/or pharmacovigilance society conferences.  
• Overnight travel required? Yes 

Minimum Education and Experience Required:

• BS in life sciences/pharmacy/nursing or related field required 
• A minimum of 8+ years’ experience in Drug Safety/PV Operations 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.

Preferred Education and Experience:

• Advanced healthcare degree preferred (i.e. MSN, Pharm.D.)