Sr. Principal Scientist (Sr. Director) , Drug Safety

Job Description

Role Overview:

Highly advanced understanding of safety/risk management to allow for overall accountability for the assigned cross departmental process owned by CSRM. The incumbent will have end to end accountability for CSRM owned process including the related SOPs and Execution resources. The incumbent is accountable to the Executive Director of CSRM Safety Science Innovation, Process and Systems with input from VP, CSRM as needed, for process direction and oversight, including ensuring consistency of execution, development and monitoring of metrics and continuous oversight for success of process as applied to the relevant products. Empowered representative of CSRM department on cross functional and cross divisional process teams. The incumbent will have continued product accountabilities including the development and execution of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/TA CSRM management as assigned.

PRIMARY ACTIVITIES:

• Serves as the end-to-end process owner, overseeing the development and maintenance of departmental SOPs and execution resources for assigned processes. Ensures appropriate cross-functional and cross-divisional stakeholder engagement on behalf of CSRM.
• Independently evaluates emerging regulations and assesses their implications for assigned processes. Leads coordination with SOP owners and relevant stakeholders to integrate necessary changes and support a compliant end-to-end process.
• Is accountable to CSRM leadership for continuous process evaluation, development and collection of metrics, compliance monitoring, and identification of opportunities for process improvement.
• Serves as the single point of contact for assigned processes for key internal and external stakeholders, contributing functional areas, and process governance committees. Partners with the Executive Director of CSRM Safety Science Innovation, Process and Systems to develop and implement mitigation plans for process risks.
• Provides expert consultation to CSRM teams on pharmacovigilance, risk management, and application of assigned processes, including but not limited to health authority interactions. Advises on process interpretation, product-specific considerations, and approaches to addressing complex issues in collaboration with relevant subject matter experts.
• Applies advanced pharmacovigilance and risk management knowledge and mentoring skills to educate stakeholders within and outside CSRM on their responsibilities. Oversees cross-divisional communication regarding process changes and emerging issues, identifies training needs, and supports development and delivery of appropriate training.
• Serves as the overall process expert and leads engagement, as needed, with auditors, inspectors, and other regulators on behalf of the company.
• For assigned product-related work,applies advanced skills in safety surveillance and in developing and evaluating pharmacovigilance activities, Risk Management Plans (RMPs), and Risk Evaluation and Mitigation Strategies (REMS), including risk minimization strategies in collaboration with the CSRM physician.
• Develops strategies for regulatory documents and prepares responses to safety inquiries from healthcare professionals, regulatory agencies, subsidiary staff, and other internal customers, in conjunction with the CSRM physician and management assigned to the product, as needed.
• Supports IPV in assessing and addressing local regulatory considerations relevant to assigned processes, in collaboration with appropriate regulatory stakeholders. Provides consultation on product-specific considerations, identifies local training needs, and supports alignment of local implementation with global processes.
• Serves as the CSRM process point of contact for post-authorisation safety studies (PASS),PSMPs, and Additional Risk Minimization Measures (ARMMs) facilitating consultation, coordination, and communication among CSRM teams, IPV, and relevant stakeholders on applicable process requirements, product-specific considerations, and emerging issues.
• Partners with the QPPV office to ensure timely awareness and escalation of process- and product-related issues that may affect its areas of responsibility, including matters relevant to the Pharmacovigilance System Master File (PSMF). Coordinates relevant information and input to support QPPV oversight and maintenance of accurate, current PSMF content within the scope of assigned processes.

SKILLS:

• Master's degree in nursing, PharmD, PA or other relevant clinical health related field preferred. Clinically relevant medical experience in the undergraduate or graduate program (e.g. nursing, pharm D, PA, or other relevant clinical health-related field).
• 10-12 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 5 years must include safety experience (e.g. PV or clinical) involving direct participation in a variety of PV processes.

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