Job Summary/Objective: 

The Director, 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 manage 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 supervise the development of periodic safety reports to meet our regulatory submission obligations, lead cross-departmental discussions on reportable events (AEs/PCs), and function as a primary 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 Director, Drug Safety & PV Operations will participate in the implementation and 

maintenance of the Global Safety Database, and help develop ex-US drug safety reporting 

procedures to ensure compliance with global 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 contracted vendors in the collection, coding, processing and reconciliation activities involving safety information in both post-marketing and clinical trial settings. 
• Support the development and finalization of periodic safety data reports to meet our reporting obligations (e.g., PADERs/ PSURs/ DSURs/ PBRERs).
• Support the development and review of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICFs, CSRs, CCDS, and RMPs.
• Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs.
• 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.
• Lead safety/quality control discussions as part of the Neurelis’ Drug Safety Committee
• Participate in the implementation and maintenance of the Global Safety Database and help develop ex-US drug safety reporting procedures to ensure compliance with global adverse event reporting requirements.
• Perform ongoing surveillance and implementation of new and updated regulations/ guidelines which impact Drug Safety & Pharmacovigilance.
• Support signal detection activities based on regular and ad hoc reviews of aggregate safety data.
• Help ensure compliance with regulatory guidelines, processes and procedures in preparation for audits and inspections.
• Support projects or other initiatives from cross-functional groups and departments (eg, Clinical Development, Regulatory Affairs, Quality) to ensure adequate safety support and timely update of safety information to drug safety physicians.
• Participate 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 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 (if applicable):

• 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 10 years drug safety/pharmacovigilance 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 database utilization, systems and applications.
• Able to effectively manage multiple vendors related to drug safety/pharmacovigilance operations.
• Prior experience in overseeing periodic safety data reports and handling expedited cases.
• Prior success in the development and implementation of SDEAs, SMPs, RMPs, SOPs and related processes/operations is preferred.
• Excellent communication and organization skills.

Preferred Education and Experience:

• An advanced degree is preferred