The Position
Currently, we are looking for Senior Specialist, Drug Safety. Develop and maintain the necessary processes to ensure high-quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations. 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. Job Description
What will you do?
Lead in the development of processes with internal and external stakeholders to ensure quality and compliance of individual adverse experience case and periodic reports. Provide expert guidance and perform safety system configuration update and maintenance activities to ensure compliant case data handling as part of the end-to-end Individual Case Safety Report (ICSR) lifecycle Study Configuration, Product Configuration, Reporting Destinations, Reportability Rules and Label Validation Files. Support Safety System Development Lifecycle (SDLC) activities to ensure these systems remain compliant with both internal and external requirements and pursue process efficiencies. Provide content for the ongoing development and expert review of the Global Safety Database User Manual, Standard Operating Procedures, and training material as needed to ensure accuracy. Provide expert guidance on the PV activities outlined by procedures (SOPs, User Manual, etc.). Responsible for drafting, negotiation, and maintenance of PV agreements and safety management plans. Identify and prioritize PV agreements and safety management plans to maintain compliance with worldwide regulatory requirements. Responsible for the end-to-end GCS&PV implementation and maintenance for select business deals. Support due diligence and qualification activities for selecting partner deals/projects. Interact closely with the business system owner for the maintenance of the Business Development Lifecycle Management system. Perform quality review of expedited and periodic reports to ensure adherence to global case processing standards and regulatory requirements. Identify, prioritize, and monitor quality issues to be resolved to maintain compliance. Lead efforts to improve departmental efficiencies and continuous improvement. Process incoming communications from internal and external sources and initiate appropriate course of action and/or response. Monitor group mailboxes utilized for the centralization of process/subject specific inquiries. Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits. Follow company always polices and legal guidelines. Develop and support processes that facilitate achievement of GCS&PV objectives. Support any other project or perform any other task deemed appropriate by management. Qualifications, Skills & Experience Required
Bachelor's degree or master's degree in life science/health care/pharmaceutical related field. Candidates are required to have at least two years of pharmacovigilance safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory. Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible to meet daily competing priorities of the business. Demonstrates leadership, and excellent communication and interpersonal skills. Ability to manage and independently drive projects to completion. Required Skills
Adverse Event Report, Auditing, Compliance Monitoring, Data Analysis, Drug Safety Surveillance, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Process Improvements, Quality Compliance, Quality Control Management, Quality Reporting, Regulatory Audits, Regulatory Compliance, Regulatory Inspections, Regulatory Reporting, Regulatory Requirements, Regulatory Reviews, Risk Management, Safety Management 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
Domestic/International VISA Sponsorship
No Travel Requirements
No Travel Required Flexible Work Arrangements
Hybrid Shift
Not Indicated Valid Driving License
No Hazardous Material(s)
n/a Job Posting End Date
11/16/2026 Requisition ID
R423310
Senior Specialist, Drug Safety in Warsaw – pracodawca: MSD Polska
MSD Polska to doskonały pracodawca, który oferuje stabilne zatrudnienie w dynamicznym środowisku produkcyjnym w Wrześni. Nasza kultura pracy opiera się na współpracy i ciągłym doskonaleniu, co stwarza liczne możliwości rozwoju zawodowego dla pracowników. Dodatkowo, dbamy o bezpieczeństwo i komfort pracy, co czyni naszą firmę atrakcyjnym miejscem dla osób poszukujących satysfakcjonującej kariery w branży technologii laserowej.
