Job Description

The Specialist, PV is responsible for executing assigned pharmacovigilance activities with minimal supervision, ensuring adherence to all applicable regulations, company policies, and procedures. This role collaborates cross-functionally and with external partners to support safe and compliant use of our products in all supported countries.

Depending on local legislation and business needs, the Specialist, PV may be designated by the PV Lead to serve as the back-up local Qualified Person for PV (QPPV), back-up Local PV Contact, or back-up Local Responsible PV person. When designated and in the absence of the PV Lead, they may manage day-to-day PV activities and serve as the PV Lead’s back-up under the oversight of a higher-level manager.

Key Responsibilities

• Execute local PV processes and activities in alignment with local legislation and company procedures, partnering with internal teams and external parties.
• Support management and negotiation of local PV agreements, local due diligence activities, and implementation of Post-Approval Safety Monitoring Programs (PSMP).
• Schedule and coordinate aggregate safety report submissions, deliver local PV trainings, and review local initiatives for PV compliance.
• Manage day-to-day adverse event case handling, including case intake, translations (English and/or local language), acknowledgments, follow-up, and submissions per PV procedures and local regulations.
• Support local PV, business partner, and vendor audits/inspections: readiness, document requests, and CAPA development and follow-through.
• Participate in issue management and compliance activities; coordinate and prepare local corrective actions.
• Contribute to development and maintenance of local PV procedures and controlled documents, ensuring alignment with local, regional, and global standards.
• Support PV self-inspections as required by PV legislation.
• Implement and oversee Risk Minimization Measures (RMM) and Additional RMM locally, as applicable; prepare/maintain/submit local Risk Management Plans (RMPs) to Health Authorities (HA), where required.
• Manage and perform local literature screening and assessment per company and local requirements, where applicable.
• Support local implementation of business continuity plans.
• Ensure proper filing, storage, and archiving of safety-related documentation per company policies and local requirements.
• Serve as a local subject matter expert (SME) on relevant PV regulations, processes, and procedures.
• Translate or quality check translations of applicable PV documents.
• Support the PV Lead in maintaining the local PV training matrix and onboarding plans.
• Review, provide input, and approve local initiatives (e.g., digital interfaces, marketing initiatives/patient programs, organized data collection systems) to ensure PV compliance, as applicable.
• Monitor Health Authority websites for potential safety issues, safety alerts, and new/revised PV requirements in line with company procedures and local legislation, as applicable.
• Liaise with local business units on safety activities and provide input to strategic decisions.
• Represent PV in cross-functional and alliance partner forums; participate in local company committees/councils impacting PV.
• Contribute to special projects or rotational assignments within or outside IPV as part of professional development.
• Complete all required trainings on time at hire and post-hire before performing relevant activities.

When serving as back-up to the PV Lead (in PV Lead’s absence):

• Comply with all relevant local laws and regulations.
• Act as local SME on PV regulations, processes, and procedures, ensuring compliance.
• Serve as point of contact for local Health Authorities and liaise with Regulatory Affairs, Medical Affairs, Clinical Research, and other functions on HA PV queries.
• Fulfill procedural tasks of the PV Lead unless otherwise delegated.
• Report or escalate potential safety or security issues.
• Partner with local business units on strategic decisions impacting PV.

Qualifications

• Education: Health, life science, or medical science degree, or equivalent based on education/experience (Hiring Manager discretion).
• Experience: At least 1 year in the pharmaceutical industry preferred (Hiring Manager discretion); general knowledge of AE reporting requirements and relevant PV regulations preferred but not required.

Skills and Competencies

• Fluent in English (written and spoken); proficient in local language.
• Strong communication, organizational, and time management skills.
• Proven ability to partner effectively internally and externally.
• Comfortable interfacing across related functions and working independently, seeking supervision only in complex situations.
• Demonstrated ability to drive process improvements that enhance quality and/or add business value.

Required Skills:

Accountability, Adaptability, Adverse Event Report, Clinical Trial Management, Communication, Complaint Management, Compliance Investigations, Data Analysis, Data Management, Detail-Oriented, Drug Safety Surveillance, Employee Training, Periodic Safety Update Reports, Pharmacovigilance, Regulatory Communications, Regulatory Compliance, Risk Management, Safety Procedures, Veterinary Products

Preferred Skills:

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Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/24/2025

*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.