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

MSD•Rahway, PA

4d•$210,400 - $331,100•Hybrid

About The Position

The Sr. Principal Scientist is accountable for end-to-end ownership of assigned cross-departmental processes owned by CSRM, including the processes’ SOPs and execution resources. Reporting to the Executive Director of CSRM Safety Science Innovation, Process and Systems, with input from the VP of CSRM as needed, the role provides process direction and oversight, promotes consistent execution, develops and monitors metrics, and maintains ongoing oversight of process performance as applied to relevant products. The incumbent represents CSRM on cross-functional and cross-divisional process teams and retains assigned product responsibilities for developing and executing pharmacovigilance and risk management plans under the direction of the CSRM physician and TA CSRM management. The role provides expert consultation on pharmacovigilance, risk management, assigned processes, and health authority interactions. It also supports product-related safety surveillance and the development and evaluation of pharmacovigilance activities, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and risk-minimization strategies in collaboration with the CSRM physician. The position coordinates with IPV, regulatory stakeholders, CSRM teams, and the QPPV office on global and local process considerations, post-authorisation safety studies (PASS), PSMPs, Additional Risk Minimization Measures (ARMMs), and relevant Pharmacovigilance System Master File (PSMF) matters. The role requires a relevant clinical health background and 10–12 years of professional experience combining clinical and pharmaceutical industry experience, including at least five years of safety experience involving direct participation in a variety of pharmacovigilance processes. A master's degree in nursing, PharmD, PA, or another relevant clinical health-related field is preferred.

Requirements

10–12 years of professional experience combining clinical and pharmaceutical industry experience.
At least five years of safety experience, such as pharmacovigilance or clinical safety, involving direct participation in a variety of PV processes.
Clinically relevant medical experience in an undergraduate or graduate program, such as nursing, PharmD, PA, or another relevant clinical health-related field.
Demonstrated expertise in pharmacovigilance and risk-management processes, including translating complex regulatory and procedural requirements into practical, product-specific guidance.
Strong consultative, written and verbal communication, facilitation, and stakeholder-management skills.
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 on global and local considerations and communicate issues requiring awareness or escalation.
Knowledge of PASS, PSMPs, ARMMs, and the relationship between assigned processes, QPPV oversight, and the PSMF.
Adverse Event Report skills.
Clinical judgment.
Cross-functional teamwork.
Detail-oriented approach.
Drug safety surveillance skills.
Global program development skills.
Pharmacovigilance knowledge.
Regulatory compliance audits knowledge or experience.
Risk-management skills.
Safety databases knowledge or experience.

Nice To Haves

A master's degree in nursing, PharmD, PA, or another relevant clinical health-related field.
Direct experience with PASS, PSMPs, and ARMMs.

Responsibilities

Own assigned CSRM processes end to end, including development and maintenance of departmental SOPs and execution resources.
Ensure appropriate engagement of cross-functional and cross-divisional stakeholders on behalf of CSRM.
Evaluate emerging regulations and assess implications for assigned processes.
Coordinate with SOP owners and stakeholders to integrate necessary changes and support compliant end-to-end processes.
Evaluate processes continuously; develop and collect metrics; monitor compliance; and identify process-improvement opportunities.
Serve as the primary contact for assigned processes for internal and external stakeholders, contributing functional areas, and process governance committees.
Partner with the Executive Director of CSRM Safety Science Innovation, Process and Systems to develop and implement mitigation plans for process risks.
Provide expert consultation on pharmacovigilance, risk management, assigned processes, health authority interactions, process interpretation, product-specific considerations, and complex issues.
Educate and mentor stakeholders within and outside CSRM on pharmacovigilance, risk management, and their process responsibilities.
Oversee cross-divisional communication about process changes and emerging issues; identify training needs and support development and delivery of training.
Lead engagement with auditors, inspectors, and other regulators as the overall process expert, as needed.
For assigned products, conduct safety surveillance and develop and evaluate pharmacovigilance activities, RMPs, REMS, and risk-minimization strategies in collaboration with the CSRM physician.
Develop regulatory-document strategies and prepare responses to safety inquiries from healthcare professionals, regulatory agencies, subsidiary staff, and internal customers, in conjunction with the assigned CSRM physician and management as needed.
Support IPV in assessing and addressing local regulatory considerations relevant to assigned processes, in collaboration with regulatory stakeholders.
Provide consultation on product-specific considerations, identify local training needs, and support alignment of local implementation with global processes.
Serve as the CSRM process contact for PASS, PSMPs, and ARMMs, facilitating consultation, coordination, and communication among CSRM teams, IPV, and relevant stakeholders.
Partner with the QPPV office to ensure timely awareness and escalation of relevant process- and product-related issues, including matters affecting the PSMF.
Coordinate information and input supporting QPPV oversight and accurate, current PSMF content within assigned process scope.