The Senior Specialist within the PV-operations Clinical Safety Strategy Operations team collaborates with our Research & Development Division colleagues to provide operational and regulatory pharmacovigilance (PV) input for company processes and standards and software system configuration that impact trial adverse event (AE) reporting and management. Maintains PV global standards for relevant activities to ensure compliance and quality aligned with SDLC (software development lifecycle) ICH/GCP International Conference on Harmonization/Good Clinical Practice) and PV requirements. The Senior Specialist stays current on existing and emerging SDLC, ICH/GCP and PV regulations and guidance. This position will focus on and execute the necessary processes required for study specific configuration of the safety database which is critical to accurate individual safety case reporting to health authorities, ethics committees and investigators in accordance with pharmacovigilance (PV) policy and regulations. The role collaborates cross-functionally in understanding and contributing to the protocol requirements to ensure configuration will be technically/operationally feasible. **Key Responsibilities**: - Process incoming requests from internal and external sources related to PV requirements and assist in development of an appropriate course of action and/or response - Participate in interdepartmental and interdivisional meetings to support individual protocol reviews and provide input for operational and regulatory PV requirements, and related processes - Participate in cross-functional meetings to support development of data collection deliverables - Cross-functional collaboration with key customers in GCS&PV;, Global Pharmacovigilance and Case Management (GPVCM), Global Data Operations (GDO) and Global Data Management and Standards (GDMS) in support of end-to-end safety data collection, safety database entry and ICSR deliverables - Assess impact of novel complex trial designs, new data collection and new/revised regulations on configuration of the safety database to ensure configuration will be technically/operationally feasible. - Partners with to communication impact to downstream safety data customers - GPVCM, GCS&PV; functional areas, Japan PV, Pharmacovigilance Partner Strategy and Management - Collaborate with Procurement and business owners of PV-related vendor contracts to incorporate PV requirements into business partner, external collaboration, joint venture, investigator initiated and acquisition trials - Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable **Education**: - Required: Bachelor's degree or master's degree in a life science/ health care/pharmaceutical related field or MD/DO/International equivalent - A minimum 3 years of work experience in pharmaceutical, clinical drug development, and/or drug safety experience required **Required Skills**: - Basic understanding of drug development - Basic knowledge of ICH, GCP and PV regulations - Experience working as part of a cross-functional team setting - Effective problem-solving skills, can analyze an issue and develop and implement solutions with oversight - Project management, and time management/organizational skills - Plans and coordinates work activities with others to maximize results - Proactively seeks out advice and information from others when addressing business issues - Strong communication skills with advanced oral and written English skills - Computer, database skills, familiar with Microsoft Office tools **Preferred**: - Experience in safety system configuration We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. **Who we are** We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. **What we look for** Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving,