Sr. Manager, Safety Operations

Employer
Tocagen
Location
San Diego, CA, United States
Posted
Aug 12, 2019
Ref
oopZ9fwF
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Function/Scope:

This position will manage the processing and reporting of individual case safety reports, and providing oversight of global pharmacovigilance (PV) operational activities in support of monitoring the safety profiles of all Tocagen's products via best practices to ensure regulatory compliance and comply with Tocagen's corporate and business partners policies.

Duties and Responsibilities Include But Are Not Limited To:

  • Provides vendor oversight of case management for ICSRs by ensuring safety functions and deliverables are of high quality in alignment with Master Service Agreement and applicable Statements of Work, including but not limited toEnsures the safety reports are properly entered into the safety database, and processed accurately,and timely regulatory submissions .
  • Ensures proper follow-up is performed.
  • Monitors the workflow in the Argus database and coordinates medical review of ICSRs
  • Leads the development and execution of safety-related plans with partners and CROs
  • Develops and review KPI's, compliance reports and quality matrics for ICSRs
  • Performs electronic submissions from the safety database, when required
  • Providing safety operational support for clinical trials, including but not limited to
    • Contributes to clinical study documents, (e.g., study protocols, CRFs) for supporting safety reporting requirements and protocol training materials for use during Site Initiation Visit (SIV).
    • Coordinates and oversees the notification of investigators and IRBs of IND safety reports/DSUR.
    • Submits configuration requests for study set-up and documentation management in the Argus safety database.
    • Develops and executes the study-specific safety management plans
    • Lead query tracking and management
    • Participates in the reviews and procedures required for database lock.
    • Lead SAE reconciliation between clinical and safety database
  • Supports the planning, preparation, writing and review of aggregate reports, including but not limited to IND safety reports, DSUR, PSURs, PBRERs:
  • Assists in signal detection and risk management, and Drug Safety Committee meetings.
  • Participates in internal audit preparation and ensures safety operations inspection readiness.
  • Contribute to process development/improvement (i.e., write or revise Standard Operations Procedures and Work Instructions) in support of GCP/GVP/Quality Assurance directives.
  • Assists development of safety data exchange agreementswith internal and external stakeholders.
  • Reviews MedDRA/WHO Drug Coding as requested.
  • Supports business development activities and interactions with corporate partners.
  • Performs other duties as required.


Desired Knowledge and Abilities:
  • Excellent communication skills; team member that can work collaboratively with colleagues across all functions and at all levels; ability to work in a cross-functional team.
  • Excellent presentation, writing, and computer skills are required.
  • Ability to maintain a problem-solving attitude in response to time demands and unexpected events.
  • Ability to work well in a deadline-driven environment.
  • Drives for results.
  • Capable of supporting multiple projects simultaneously.
  • Travel as needed.


Education and Experience:
  • Bachelor's degree in life sciences, nursing, pharmacy, or medicine.
  • Minimum of 5 years of experience in drug safety and pharmacovigilance, preferably in a Sponsor setting. Working knowledge and experience of US/EU PV regulations. .
  • Proven hands-on experience with ARGUS safety database
  • Good knowledge of MedDRA and WHO Drug coding