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

Merck•North Wales, PA

6d•$210,400 - $331,100•Hybrid

About The Position

The Sr. Principal Scientist serves as the end-to-end owner of an assigned cross-departmental process within CSRM, with accountability for its direction, oversight, consistent execution, SOPs, execution resources, metrics, compliance monitoring, and continuous improvement. The role represents CSRM on cross-functional and cross-divisional process teams and serves as the principal contact for internal and external stakeholders, governance committees, auditors, inspectors, and regulators. The incumbent reports to the Executive Director of CSRM Safety Science Innovation, Process and Systems for process direction and oversight, with input from the VP, CSRM as needed. The position provides expert consultation and education on pharmacovigilance, risk management, regulatory requirements, process interpretation, and product-specific considerations. It also retains assigned product responsibilities, including developing and executing pharmacovigilance and risk management plans under the direction of the CSRM physician and TA CSRM management. Work includes safety surveillance, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), regulatory-document strategies, and responses to safety inquiries. The role coordinates with IPV, regulatory stakeholders, and the QPPV office on local regulatory considerations, PASS, PSMPs, Additional Risk Minimization Measures (ARMMs), QPPV oversight, and relevant Pharmacovigilance System Master File (PSMF) content. The position is hybrid and is based primarily in North Wales, Pennsylvania. The role offers a base salary range of $210,400 to $331,100 for the primary location, with eligibility for an annual bonus and long-term incentive if applicable.

Requirements

10–12 years of professional experience combining clinical and pharmaceutical-industry experience.
At least 5 years of safety experience, such as pharmacovigilance or clinical safety, including direct participation in a variety of PV processes.
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, 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 developing and delivering training.
Ability to partner effectively with CSRM teams, IPV, regulatory stakeholders, and the QPPV office to address global and local considerations and communicate matters requiring awareness or escalation.
Clinical experience in an undergraduate or graduate program in nursing, PharmD, PA, or another relevant clinical health-related field.
Required skills listed: Adverse Event Report, Clinical Judgment, Cross-Functional Teamwork, Detail-Oriented, Drug Safety Surveillance, Global Program Development, Pharmacovigilance, Regulatory Compliance Audits, Risk Management, and Safety Databases.

Nice To Haves

Master's degree in nursing, PharmD, PA, or another relevant clinical health-related field preferred.
Direct experience with PASS, PSMPs, and ARMMs, and knowledge of their interface with QPPV oversight and the PSMF.

Responsibilities

Own assigned CSRM processes end to end, including development and maintenance of departmental SOPs and execution resources, and ensure appropriate cross-functional and cross-divisional stakeholder engagement.
Evaluate emerging regulations and coordinate with SOP owners and stakeholders to incorporate necessary changes and maintain a compliant end-to-end process.
Continuously evaluate processes, develop and collect metrics, monitor compliance, and identify process-improvement opportunities.
Serve as the single point of contact for assigned processes with internal and external stakeholders, contributing functional areas, and 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 to CSRM teams on pharmacovigilance, risk management, assigned processes, health authority interactions, process interpretation, and product-specific considerations.
Educate and mentor stakeholders on pharmacovigilance, risk management, and process responsibilities; coordinate communication about process changes and emerging issues; identify training needs and support training development and delivery.
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 other internal customers, with the assigned CSRM physician and management as needed.
Support IPV in assessing and addressing local regulatory considerations related to assigned processes; provide product-specific consultation, 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, and coordinate information supporting QPPV oversight and accurate, current PSMF content within the assigned process scope.