Senior Specialist, Drug Safety
Merck Gruppe - MSD Sharp & Dohme, Rahway, New Jersey, us, 07065
Overview
The Senior Specialist collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance company policies, processes, standards and software system configuration that impact individual case safety reports, aggregate reports and downstream medical review and safety signaling activities. Maintains Pharmacovigilance global standards for relevant activities to ensure compliance and quality aligned with (software development lifecycle), and global requirements.
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 deliverables.
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.
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.
Track Advent Events 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.
Education Requirement
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, health care, clinical trials, clinical drug development, and/or drug safety experience required.
Advanced English - Business level
Required Qualifications & Skills
Knowledge and understanding of Pharmacovigilance processes and regulations
Knowledge of safety reporting data collection requirements
Problem solving and implementation of solutions with oversight
Experience working in a cross-functional team setting
Strong interpersonal skills and strong communication skills
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
Required Skills
Accountability
Adaptability
Adverse Event Report
Auditing
Biopharmaceuticals
Business Processes
Communication
Compliance Monitoring
Data Analysis
Decision Making
Drug Development
Drug Safety Surveillance
Immunotherapy
Medical Review
Pharmaceutical Regulatory Compliance
Pharmacovigilance
Project Management
Regulatory Compliance
Regulatory Reporting
Regulatory Requirements
Risk Management
Safety Procedures
Software Development
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
Other 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:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
02/6/2026
*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:
R382424
#J-18808-Ljbffr
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 deliverables.
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.
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.
Track Advent Events 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.
Education Requirement
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, health care, clinical trials, clinical drug development, and/or drug safety experience required.
Advanced English - Business level
Required Qualifications & Skills
Knowledge and understanding of Pharmacovigilance processes and regulations
Knowledge of safety reporting data collection requirements
Problem solving and implementation of solutions with oversight
Experience working in a cross-functional team setting
Strong interpersonal skills and strong communication skills
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
Required Skills
Accountability
Adaptability
Adverse Event Report
Auditing
Biopharmaceuticals
Business Processes
Communication
Compliance Monitoring
Data Analysis
Decision Making
Drug Development
Drug Safety Surveillance
Immunotherapy
Medical Review
Pharmaceutical Regulatory Compliance
Pharmacovigilance
Project Management
Regulatory Compliance
Regulatory Reporting
Regulatory Requirements
Risk Management
Safety Procedures
Software Development
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
Other 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:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
02/6/2026
*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:
R382424
#J-18808-Ljbffr