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About the Role

The Regional PV Officer for the EMEA region supports and oversees pharmacovigilance activities, acting as a subject matter expert for identified regional and global activities. This role liaises with global and cross-departmental colleagues to ensure compliance and operational excellence in pharmacovigilance.

Responsibilities

• Support the implementation, maintenance, and continuous improvement of the IPV Quality Management System (QMS).
• Provide expert guidance and operational support to country PV teams on pharmacovigilance matters.
• Support audits and inspections, including readiness activities and execution.
• Manage Country PV Audit CAPA, ensuring CAPA development in response to findings.
• Support knowledge-sharing related to reportability rules and reference data in the Global Safety Database.
• Interface with Country PV and GCS&PV staff for establishment and maintenance of regionally applicable global standards/systems.
• Execute regionally required pharmacovigilance submissions, such as Aggregate reports.
• Provide guidance on complex cross-functional scenarios and innovative solutions.
• Perform compliance monitoring activities for safety reports and lead or participate in non-compliance investigations.
• Coordinate translation of PV documents as applicable.
• Support the preparation, review, and maintenance of Local, Regional, and/or Global IPV procedures.
• Serve as a documentation steward for the IPV organization.
• Provide guidance and support on compliance activities.
• Ensure appropriate contract management activities for Regional PV agreements.
• Support PV intelligence monitoring, interpretation, and implementation of new/updated PV legislations.
• Coordinate and gather Pharmacovigilance information and/or regulatory requirements from local country operations.
• Ensure PSMF or CCPD process/updates are accurate.
• Support compliance metrics for additional risk minimization measures and establish key performance indicators.
• Support IPV training execution strategy and IPV training curricula maintenance.
• Support country and regional PV teams by providing subject matter expertise related to the Global Safety Database.
• Participate in regional/Cluster/global meetings and support planning and facilitation of meetings.
• Serve as back-up to PV Lead or any IPV role within assigned countries for certain activities.
• Participate and represent IPV on special projects or rotational assignments.
• Act as a mentor for PV staff on pharmacovigilance topics.
• Complete all required trainings by due dates and ensure activities are conducted in compliance with regulations, procedures, and policies.

Requirements

• Must complete all required/applicable trainings assigned at the time of hire and after hire by the due dates, before performing the activity.
• Ensure all activities are conducted in compliance with applicable regulations, internal procedures, and company policies, consistently meeting quality standards.

Skills

• Adverse Event Report
• Contract Management
• Drug Safety Surveillance
• Pharmaceutical Regulatory Compliance
• Pharmacovigilance
• Quality Standards
• Regulatory Compliance
• Regulatory Reporting
• Regulatory Requirements
• Risk Management
• Strategic Planning

Location

• EMEA

Work Type

• Hybrid
• Regular

About the Company

• 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 place, introductions are position specific.
• Please, no phone calls or emails.