Senior Manager, Drug Safety & Pharmacovigilance Operations

Neurelis Inc•San Diego, CA

23h

About The Position

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.

Requirements

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.

Nice To Haves

Advanced healthcare degree preferred (i.e. MSN, Pharm.D.)
Minimum 5 years’ experience in Drug Safety/PV Operations.

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.