Neurelis, Inc.

Senior Manager, Drug Safety – Pharmacovigilance Operations

OperationsOperationsFull TimeRemoteSeniorTeam 51-200Since 2015H1B No SponsorCompany Site LinkedIn

Location

California

Posted

47 days ago

Salary

$162K - $180K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglish

Job Description

• Responsibility for managing safety and PV related activities involving VALTOCO® and investigational compounds • Supervision of external pharmacovigilance vendors regarding the collection, processing, and reconciliation of drug safety information • Support the development of periodic safety reports to meet regulatory submission obligations • Participate in cross-departmental discussions on reportable events and function as a drug safety/PV contact for both internal colleagues and external stakeholders • Participate in the maintenance of the Global Safety Database and help develop global drug safety reporting procedures

Job 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.