Global Safety Officer; GSO biotechnology Southern California

Global Safety Officer (GSO) for a worldwide biotechnology company located in Southern California

The GSO leads and directs global projects providing continuous assessment, management and communication of the benefit/risk profile for company products in clinical development from early to late stage development.

Role/

Purpose:

Reporting to the Executive Director of Global Safety establishes the direction and priorities of the Global Safety Team and is accountable for all product safety related decisions for assigned compounds in Clinical Development including post-marketing studies.

Functions as the key interface between the Global Safety Team, Therapeutic Area Head, Global Safety Senior Management, Group Regulatory Affairs and other company functional areas including Global Development.

Will be responsible for the timely communication of safety recommendations and/or actions from the Global Safety Team to internal and external stakeholders

This role leads single projects which can be of moderate or high complexity/scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head

Key Responsibilities:

Lead responses to regulatory inquiries regarding safety, including evaluating questions, assigning responsibility, determining data needs, reviewing, approving and submitting the response

Develops and supports action plans to evaluate safety concerns, internal review and escalation, risk management strategy, execution, and communication

Lead development of strategy and creation of product risk management plans including maintenance and updates

Manages quarterly product safety reviews execution and closure of recommendations

Represent Global Safety in meetings with Regulatory authorities

Participate in planning, review and sign off of clinical trial safety documents for content

Provide input to potential in-licensing opportunities, safety interactions, and pharmacovigilance agreements with commercial partners

Participate in planning, providing strategy and content input, and approve/sign- off on aggregate safety reports (e.g. PSURs, ASRs) and other reports needed for regulatory authorities

Accountable for identification, assessment, and communication of potential safety signals as leaders of GST Pharmacovigilance activities

Responsible for regulatory inspection readiness within functional group

Manage GST in support of Therapeutic Area Head ensuring adequate resource planning

Qualifications

• Medical Degree (MD) or international equivalent and management experience
• Accredited fellowship or clinical experience in a relevant therapeutic area specialty.

Preferred Qualifications

• Board eligibility or Board certification is preferred.
• Previous drug safety experience in pharmacovigliance and clinical risk management of clinical drug development in the biotech/pharmaceutical industry.
• Experience could range from 3 to 7 years.