Senior Pharmacovigilance Specialist

MSD; Espoo; Presencial; EUR 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

Merck & Co., Inc. is seeking a Senior Pharmacovigilance Specialist to manage local PV activities in alignment with regulatory requirements. The role involves AEs case handling, translation, and submission, plus supporting audits and regulatory inspections.

You will contribute to local PV procedures, training, and collaboration with cross-functional teams. A moderate travel expectation and a hybrid work setup are involved.

Formación

• Health, life science degree or equivalent by education/experience.
• At least 2 years of experience in the pharmaceutical industry.
• Fluent in English; local language proficiency as applicable.

Responsabilidades

• Execute local PV processes in line with local regulations and company procedures.
• Day-to-day adverse events case management including translations and submissions.
• Support PV audits/inspections and CAPA development.
• Develop/maintain local PV procedures and controlled documents.

Conocimientos

AE reporting

Regulatory compliance

PV audits

Project management

Negotiation

Educación

Health/Life science degree

Descripción del empleo

Senior Pharmacovigilance Specialist

Brief Description of Position: The Senior Specialist, PV is responsible for specified PV activities (as delegated or assigned by their manager) and is able to work on these activities independently. The Senior Specialist, PV is responsible for ensuring adherence to all applicable regulations, company policies and procedures. The Sr. Specialist, PV may be designated by the PV lead to serve as the Back-up (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. When designated, in the absence of the PV Lead, they may manage day-to-day PV activities and serve as their back-up with the supervision by a higher-level manager, as required.

The items listed below are activities that can be performed by the role as assigned by the manager and are applicable for all supported countries. Additional local specific tasks and responsibilities may be further described in the section below entitled “Additional Local Specific Activities”. Responsible for execution of local PV processes and activities in collaboration with applicable internal functional areas and external parties, ensuring alignment with local legislation and local/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, review of local initiatives for compliance with PV requirements, communication of safety issues.

Responsible for day-to-day adverse events case management which may include case intake, translations (to English and/or local language (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations. Participates in and supports local PV, business partner and vendor audits and inspections including readiness activities and the development of CAPAs in response to findings/observations. Participates in issue management/compliance activities and coordinates the preparation of necessary local corrective actions. Assists in developing and maintaining local PV procedures and controlled documents in compliance with local, regional and global standards, to ensure global quality PV data. Documents may include but are not limited to standard operating procedures, other procedural documents, training materials, controlled Pharmacovigilance Documents e.g. Company Core Pharmacovigilance Document. Conducts and/or supports PV self-inspections as required by PV Legislations (where applicable). Prepare/maintain/submit local RMPs to the local HA (as applicable). Responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per local procedure and ensures compliance with local legislation.

Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable). Support local implementation of applicable business continuity plans. Responsible for filing, storage and archiving safety-related documentation in accordance with company’s policies and local requirements. May serves as a local SME on relevant PV regulations, processes and procedures. May coordinate and/or completes translation of applicable PV documents and ensures a QC check is performed by a second person for any in-house translations. Supports PV Lead in maintaining the local PV Training matrix and onboarding plans. May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable. May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).

Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions. Represents PV in cross-functional organizational and alliance partner forums as needed. Participates on local company committees and councils for matters impacting PV as assigned. Participate in PV engagement in relevant external associations/industry forums, and regulatory authorities, as applicable. May be responsible for management of one or more direct reports including recruitment, training, development, and performance management as applicable. Participates in special projects or rotational assignments within or outside of IPV as part of their professional development. Responsible for completing all required/applicable trainings assigned at time of hire and after hire, by the due dates and before performing the activity. When serving as back-up of the PV Lead in PV Lead absence performs the following key activities: Serves as local subject matter expert on relevant PV regulations, processes and procedures and ensures compliance. Serves as the point of contact for local Health Authorities and liaises with Regulatory Affairs, Medical Affairs, Clinical Research and other functional areas for Health Authority questions regarding PV. Fulfills procedural tasks of the PV Lead unless otherwise delegated. Reports or escalates potential safety or security issues. Liaises with local business units to contribute to strategic decisions that impact PV.

Extent of Travel 0-5%

Qualifications, Skills & Experience

Education: Health, life science, or medical science degree or equivalent by education/experience (Hiring Manager discretion permitted).

Work Experience: At least 2 years of experience in the pharmaceutical industry is preferred (Hiring Manager discretion permitted). Supervisory experience managing people/teams/contractors is preferred if the position will be managing staff (Hiring Manager discretion permitted).

In-depth knowledge of AE reporting requirements and relevant PV regulations, PV quality management systems and be an expert in PVprocesses and activities. Experience with PV audits and/or PV Health Authority Inspections.

Job-specific competencies & skills: Must be fluent in English (written and spoken) while proficient in local language. Ability to travel within the region and globally. Advanced interpersonal communications, organizational, and presentation skills. Ability to work in partnership with others (internally and externally). Advanced negotiation and influencing skills. Ability to interface broadlywith colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations. Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business. Demonstrates advanced strategic thinking and project management skills including prioritization of tasks.

Required Skills

• Adverse Event Report
• Compliance Monitoring
• Corrective Action Management
• Cross-Functional Project Management
• Drug Safety Surveillance
• Global Coordination
• Pharmaceutical Regulatory Compliance
• Quality Management
• Regulatory Compliance
• Regulatory Management
• Regulatory Reporting
• Regulatory Requirements
• Risk Management
• Safety Management
• Strategic Thinking
• Veterinary Products

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 10/14/2026 *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.

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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.