Job Code:
Location: West Coast

Basic Qualifications

- Medical Degree (MD) or international equivalent

- Previous management experience

Preferred Qualifications:

- Accredited fellowship or clinical experience in relevant therapeutic area specialty

- Clinical experience, including training

- Previous drug safety, biotech/ pharmaceutical or regulatory agency experience

Job Summary

This is an opportunity for a Director position in the PBRAM group within Global Safety. The PBRAM group provides continuous assessment, management and timely communication of the benefit/risk profile for all products.

Role/Purpose:

- The Global Safety Officer (GSO) leads by establishing the direction and priorities of the GST and is accountable for all product safety related GST decisions for assigned products

- Key interface between the GST, TAH, AGS Sr. Management, GRA, and other functional areas including Global development

- The GSO supported by the GSSL is responsible for the timely communication of safety recommendations and/or actions from the GST 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 include:

- Lead responses to regulatory enquiries regarding safety, including evaluating the question, 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

- Accountable for safety content of Global Development Plans

- Contribute to and sign off on DMC and adjudication charters

- Represent AGS at meetings with Regulatory authorities

- Participate in planning, review and sign off of clinical trial safety documents for content (includes CSS, 120 Day safety update, protocol safety sections, CSR#s, ICF#s, study safety monitoring plans, Investigator Brochures)

- Drive and support the development and maintenance of DCSI and CDS safety sections via leadership of the GST

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

- Participate in planning, provide strategy and content input, and sign off on aggregate safety reports (e.g. PSURs, ASRs)

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

- Responsible for regulatory inspection readiness within functional group

- Manage GST in support of Therapeutic Area Head ensuring workload/resource planning

- Collaborate, review and sign off SOPs, Business Practices, and Training Manuals as necessary