[Hiring] Director, Drug Safety & Pharmacovigilance Operations @Neurelis Inc
Mar 18, 2025 - Neurelis Inc is hiring a remote Director, Drug Safety & Pharmacovigilance Operations. đź’¸ Salary: unspecified. đź“ŤLocation: USA.
Role Description
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.
- Supervise the development of periodic safety reports to meet regulatory submission obligations.
- Lead cross-departmental discussions on reportable events (AEs/PCs).
- Function as a primary drug safety/PV contact for both internal colleagues and external stakeholders.
- Participate in the implementation and maintenance of the Global Safety Database.
- Help develop ex-US drug safety reporting procedures to ensure compliance with global adverse event reporting requirements.
- Function as a high-impact contributor within a small and rapidly growing company.
Qualifications
- 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.
- 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.
Requirements
- 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.
Benefits
- Ability to travel up to 15% to attend medical and/or pharmacovigilance society conferences.
- Overnight travel required.
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.
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| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
đź’¸
unspecified
|
Remote
Location
USA
|
|
Job Type
unspecified
|
Posted
Mar 18, 2025
|
| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
