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

Job description

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. Demonstrated expertise in pharmacovigilance and risk management processes, with the ability to translate complex regulatory and procedural requirements into practical, product-specific guidance. Strong consultative, written and verbal communication, facilitation, and stakeholder-management skills, including the ability to influence without direct authority and resolve complex cross-functional issues. Demonstrated experience in process governance, compliance monitoring, metrics interpretation, continuous improvement, and development and delivery of training. Ability to partner effectively with CSRM teams, IPV, regulatory stakeholders, and the QPPV office to address global and local considerations and communicate issues requiring awareness or escalation. Knowledge of PASS, PSMPs, ARMMs and the interface of assigned processes with QPPV oversight and the PSMF; direct experience in these areas preferred. Required Skills: Adverse Event Report, Clinical Judgment, Cross-Functional Teamwork, Detail-Oriented, Drug Safety Surveillance, Global Program Development, Pharmacovigilance, Regulatory Compliance Audits, Risk Management, Safety Databases Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd) Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $210,400.00 - $331,100.00 This range reflects the Company's reasonable expecta