Sr. Spclst, Drug Safety

Job description

Job Description The Senior Specialist, PV-O&GPE collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance (PV) company policies, processes, standards and software system configuration that impact individual case safety reports (ICSR), aggregate reports and downstream medical review and safety signaling activities. Maintains PV global standards for relevant activities to ensure compliance and quality aligned with SDLC (software development lifecycle), ICH/GCP and global PV requirements. The Senior Specialist stays current on existing and emerging SDLC, ICH/GCP and PV regulations and guidance. Core Responsibilities Develop and maintain the necessary processes and training to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations Participate in interdepartmental and cross-functional meetings to support operational and regulatory PV requirements and deliverable Maintain knowledge of PV regulations related to drugs, vaccines, biologics and devices. Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations 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 Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable Support integration of acquisitions, collaborations, and partnerships Collaborates with MRK IT to implement and manage system improvements and updates to the safety database and systems supporting PV activities Key Responsibilities Participate and/or lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual case and aggregate safety reports Perform quality review of individual case and aggregate safety reports to ensure adherence to global case processing standards and regulatory requirements Perform investigations of late individual case and aggregate safety reports, including root cause analysis and development of corrective and preventive action plans Compile metrics for individual case and aggregate safety reports Develop and maintain protocol template safety language for both interventional and non-interventional protocols and provide approval for protocol specific exceptions, with oversight Execute software system UAT (user acceptance testing) Support implementation of new and standard clinical trial collection deliverables Support development and maintenance of the label Validation Datasheets for company products Track AE QIR and MDCP-related metrics Contribute to aggregate safety reports content such as generating and/or reviewing output and patient exposure data Collaborate with Business Process Owners to improve departmental efficiencies and continuous improvement Monitor group mailboxes utilized for the centralization of process/subject specific inquiries Serve as subject matter expert for individual case and aggregate safety report types Qualifications, Skills & Experience Required Qualifications & Skills: Basic knowledge and understanding of ICH/GCP & PV processes and regulations ​ Basic knowledge of safety reporting data collection requirements​ Basic problem solving and implementation of solutions with oversight​ Experience working in a cross-functional team setting​ Strong interpersonal skills Strong communication skills with advanced oral & written business level English​ Project management – ability to plan and coordinate work activities with others, time management skills​. Able to drive projects to completion Strong attention to detail and production of quality work Proactively seeks out advice and information from others when addressing business issues Computer, database skills, familiar with Microsoft Office tools Education Requirement: 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 2 years of work experience in pharmaceutical, clinical drug development, and/or drug safety experience required #LI-DNI Required Skills: Adaptability, Adverse Event Report, Auditing, Business Management, Business Processes, Collaborative Development, Compliance Monitoring, Data Analysis, Decision Making, Drug Development, Drug Safety Surveillance, Medical Care, Pharmaceutical Regulatory Compliance, Pharmacology, Pharmacovigilance, Project Human Resource Management, Project Management, Regulatory Compliance, Regulatory Reporting, Risk Management, Software Development, Strategic Collaborations, Strategic Planning, Training and Development, Veterinary Products Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 07/17/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.