PV Specialist (Maternity Leave Cover)
Merck
PV Specialist (Maternity Leave Cover)
Job Description
Job DescriptionWe are seeking a Specialist, PV to join our team as a maternity leave cover. This is a fixed-term role, with the contract renewed on an annual basis, and the expected contract length is until Spring 2029.The Specialist, PV is responsible for specified pharmacovigilance (PV) activities, as delegated and assigned by their manager, and is expected to perform these tasks with minimal supervision. The role ensures adherence to all applicable regulations, company policies, and procedures.In addition, the Specialist, PV may be designated by the PV Lead to serve as the Back-up (BU) Local Qualified Person for Pharmacovigilance (QPPV) / BU Local PV Contact / BU Local Responsible PV Person, as required by local PV legislation. When designated, and in the absence of the PV Lead, the Specialist, PV may manage day-to-day PV activities and act as back-up under supervision from a higher-level manager, as required.Key Responsibilities:The responsibilities listed below may be assigned by the manager and apply to all supported countries. Additional local-specific responsibilities may be defined separately under Additional Local Specific Activities.Local PV Operations and ComplianceExecute local PV processes and activities in collaboration with internal functional areas and external parties, ensuring alignment with local legislation and regional/global company procedures and policies.Activities may include, but are not limited to:Management and negotiation of local PV agreementsLocal due diligence activitiesPost-Approval Safety Monitoring Program (PSMP) implementationScheduling and coordinating aggregate safety report submissionsConducting local trainingReviewing local initiatives for PV complianceCommunicating safety issuesCase Management and ReportingSupport day-to-day adverse event case management, which may include:Case intakeTranslations (English and/or local language, as applicable)AcknowledgementsFollow-up activitiesSubmission activities in accordance with PV procedures and country regulationsAudit, Inspection, and Compliance SupportSupport local PV, business partner, and vendor audits and inspections, including readiness activities, document requests, and CAPA activities.Participate in issue management and compliance activities and coordinate/prepare necessary local corrective actions.Support PV self-inspections as required by PV legislation, where applicable.Documentation, Procedures, and TrainingSupport development and maintenance of local PV procedures and controlled documents in compliance with local, regional, and global standards to ensure global quality PV data.Responsible for filing, storage, and archiving of safety-related documentation in accordance with company policies and local requirements.Support the PV Lead in maintaining the local PV training matrix and onboarding plans.Complete all required and applicable trainings assigned at the time of hire and after hire, by the due dates, and before performing the activity.Risk Management and Literature ActivitiesMay be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally, in line with department policy and local legislation.Prepare, maintain, and submit local RMPs to the local Health Authority, as applicable.May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements, as applicable.Cross-Functional and Strategic SupportSupport local implementation of applicable business continuity plans.Serve as local Subject Matter Expert on relevant PV regulations, processes, and procedures.Translate or quality-check translations of applicable PV documents.May be responsible for reviewing, providing input on, and approving local initiatives such as digital interfaces, marketing initiatives, patient programs, organized data collection systems, and other programs to ensure PV compliance.May be responsible for Health Authority website monitoring for potential safety issues, safety alerts, and new or revised PV requirements, in compliance with company procedures and local legislation.Liaise with local business units to keep them informed of safety activities and provide input on strategic decisions.Represent PV in cross-functional organizational and alliance partner forums as needed.Participate in local company committees and councils for matters impacting PV, as assigned.Participate in special projects or rotational assignments within or outside of IPV as part of professional development.Back-Up Responsibilities in PV Lead Absence:Comply with all requirements set forth in local laws and regulations.Serve as the local subject matter expert on relevant PV regulations, processes, and procedures and ensure compliance.Act as point of contact for local Health Authorities and liaise with Regulatory Affairs, Medical Affairs, Clinical Research, and other functional areas regarding PV questions.Perform procedural tasks of the PV Lead unless otherwise delegated.Report or escalate potential safety or security issues.Liaise with local business units to contribute to strategic decisions impacting PV.Education:Degree in Health, Life Science, Medical Science, or equivalent through education/experience, at the hiring manager’s discretion.Work Experience:At least 1 year of experience in the pharmaceutical industry is preferred, at the hiring manager’s discretion.General knowledge of AE reporting requirements and relevant PV regulations is preferred, but not required.Skills and Competencies:Fluent in English, both written and spoken, with proficiency in the local language.Strong communication, organizational, and time management skills.Ability to work in partnership with others, both internally and externally.Ability to interface broadly with colleagues across related functions and work independently, with minimal supervision except in the most complex situations.Demonstrated ability to drive change that improves processes, enhances quality, and/or adds value to the business.What We Offer:A maternity leave cover position with the possibility of annual contract renewalAn expected contract duration until Spring 2029The opportunity to work in a highly collaborative and international environmentA role with broad exposure to pharmacovigilance activities across local, regional, and global levelsOpportunities to build expertise in PV compliance, safety operations, and cross-functional collaborationThe chance to contribute to process improvement, quality enhancement, and patient safetyA supportive team environment with opportunities for professional development and participation in special projects or rotational assignmentsRequired Skills: Adverse Event Report, Data Analysis, Drug Safety Surveillance, PharmacovigilancePreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: Project Temps (Fixed Term)Relocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:YesHazardous Material(s):n/aJob Posting End Date:09/30/2026*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.
Locations
- BGR - Sofia City - Sofia (Nikola)
Preferred Qualifications
- Current Employees apply HERE (experience)
- Current Contingent Workers apply HERE (experience)
Responsibilities
- The responsibilities listed below may be assigned by the manager and apply to all supported countries. Additional local-specific responsibilities may be defined separately under Additional Local Specific Activities.
- Local PV Operations and Compliance
- Execute local PV processes and activities in collaboration with internal functional areas and external parties, ensuring alignment with local legislation and regional/global company procedures and policies.
- Activities may include, but are not limited to:Management and negotiation of local PV agreementsLocal due diligence activitiesPost-Approval Safety Monitoring Program (PSMP) implementationScheduling and coordinating aggregate safety report submissionsConducting local trainingReviewing local initiatives for PV complianceCommunicating safety issues
- Execute local PV processes and activities in collaboration with internal functional areas and external parties, ensuring alignment with local legislation and regional/global company procedures and policies.
- Activities may include, but are not limited to:
- Management and negotiation of local PV agreements
- Local due diligence activities
- Post-Approval Safety Monitoring Program (PSMP) implementation
- Scheduling and coordinating aggregate safety report submissions
- Conducting local training
- Reviewing local initiatives for PV compliance
- Communicating safety issues
- Case Management and Reporting
- Support day-to-day adverse event case management, which may include:Case intakeTranslations (English and/or local language, as applicable)AcknowledgementsFollow-up activitiesSubmission activities in accordance with PV procedures and country regulations
- Support day-to-day adverse event case management, which may include:
- Translations (English and/or local language, as applicable)
- Acknowledgements
- Follow-up activities
- Submission activities in accordance with PV procedures and country regulations
- Audit, Inspection, and Compliance Support
- Support local PV, business partner, and vendor audits and inspections, including readiness activities, document requests, and CAPA activities.
- Participate in issue management and compliance activities and coordinate/prepare necessary local corrective actions.
- Support PV self-inspections as required by PV legislation, where applicable.
- Support local PV, business partner, and vendor audits and inspections, including readiness activities, document requests, and CAPA activities.
- Participate in issue management and compliance activities and coordinate/prepare necessary local corrective actions.
- Support PV self-inspections as required by PV legislation, where applicable.
- Documentation, Procedures, and Training
- Support development and maintenance of local PV procedures and controlled documents in compliance with local, regional, and global standards to ensure global quality PV data.
- Responsible for filing, storage, and archiving of safety-related documentation in accordance with company policies and local requirements.
- Support the PV Lead in maintaining the local PV training matrix and onboarding plans.
- Complete all required and applicable trainings assigned at the time of hire and after hire, by the due dates, and before performing the activity.
- Support development and maintenance of local PV procedures and controlled documents in compliance with local, regional, and global standards to ensure global quality PV data.
- Responsible for filing, storage, and archiving of safety-related documentation in accordance with company policies and local requirements.
- Support the PV Lead in maintaining the local PV training matrix and onboarding plans.
- Complete all required and applicable trainings assigned at the time of hire and after hire, by the due dates, and before performing the activity.
- Risk Management and Literature Activities
- May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally, in line with department policy and local legislation.
- Prepare, maintain, and submit local RMPs to the local Health Authority, as applicable.
- May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements, as applicable.
- May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally, in line with department policy and local legislation.
- Prepare, maintain, and submit local RMPs to the local Health Authority, as applicable.
- May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements, as applicable.
- Cross-Functional and Strategic Support
- Support local implementation of applicable business continuity plans.
- Serve as local Subject Matter Expert on relevant PV regulations, processes, and procedures.
- Translate or quality-check translations of applicable PV documents.
- May be responsible for reviewing, providing input on, and approving local initiatives such as digital interfaces, marketing initiatives, patient programs, organized data collection systems, and other programs to ensure PV compliance.
- May be responsible for Health Authority website monitoring for potential safety issues, safety alerts, and new or revised PV requirements, in compliance with company procedures and local legislation.
- Liaise with local business units to keep them informed of safety activities and provide input on strategic decisions.
- Represent PV in cross-functional organizational and alliance partner forums as needed.
- Participate in local company committees and councils for matters impacting PV, as assigned.
- Participate in special projects or rotational assignments within or outside of IPV as part of professional development.
- Support local implementation of applicable business continuity plans.
- Serve as local Subject Matter Expert on relevant PV regulations, processes, and procedures.
- Translate or quality-check translations of applicable PV documents.
- May be responsible for reviewing, providing input on, and approving local initiatives such as digital interfaces, marketing initiatives, patient programs, organized data collection systems, and other programs to ensure PV compliance.
- May be responsible for Health Authority website monitoring for potential safety issues, safety alerts, and new or revised PV requirements, in compliance with company procedures and local legislation.
- Liaise with local business units to keep them informed of safety activities and provide input on strategic decisions.
- Represent PV in cross-functional organizational and alliance partner forums as needed.
- Participate in local company committees and councils for matters impacting PV, as assigned.
- Participate in special projects or rotational assignments within or outside of IPV as part of professional development.
- Comply with all requirements set forth in local laws and regulations.
- Serve as the local subject matter expert on relevant PV regulations, processes, and procedures and ensure compliance.
- Act as point of contact for local Health Authorities and liaise with Regulatory Affairs, Medical Affairs, Clinical Research, and other functional areas regarding PV questions.
- Perform procedural tasks of the PV Lead unless otherwise delegated.
- Report or escalate potential safety or security issues.
- Liaise with local business units to contribute to strategic decisions impacting PV.
- Comply with all requirements set forth in local laws and regulations.
- Serve as the local subject matter expert on relevant PV regulations, processes, and procedures and ensure compliance.
- Act as point of contact for local Health Authorities and liaise with Regulatory Affairs, Medical Affairs, Clinical Research, and other functional areas regarding PV questions.
- Perform procedural tasks of the PV Lead unless otherwise delegated.
- Report or escalate potential safety or security issues.
- Liaise with local business units to contribute to strategic decisions impacting PV.
Benefits
- general: A maternity leave cover position with the possibility of annual contract renewal
- general: An expected contract duration until Spring 2029
- general: The opportunity to work in a highly collaborative and international environment
- general: A role with broad exposure to pharmacovigilance activities across local, regional, and global levels
- general: Opportunities to build expertise in PV compliance, safety operations, and cross-functional collaboration
- general: The chance to contribute to process improvement, quality enhancement, and patient safety
- general: A supportive team environment with opportunities for professional development and participation in special projects or rotational assignments
- general: A maternity leave cover position with the possibility of annual contract renewal
- general: An expected contract duration until Spring 2029
- general: The opportunity to work in a highly collaborative and international environment
- general: A role with broad exposure to pharmacovigilance activities across local, regional, and global levels
- general: Opportunities to build expertise in PV compliance, safety operations, and cross-functional collaboration
- general: The chance to contribute to process improvement, quality enhancement, and patient safety
- general: A supportive team environment with opportunities for professional development and participation in special projects or rotational assignments
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