Sr. Spclst, Drug Safety

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

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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.

Requisition ID: R406532