Merck
Job Description
The Senior Pharmacovigilance (PV) Specialist is responsible for executing assigned local PV activities independently and ensuring full compliance with applicable regulations, company policies, and procedures. The role supports day-to-day pharmacovigilance operations across one or more countries, working closely with internal teams and external partners to maintain patient safety, regulatory compliance, and high-quality safety data.
As required by local PV legislation and business needs, the Senior PV Specialist may also be designated as the back-up local Qualified Person for PV (QPPV), back-up Local PV Contact, or back-up Local Responsible PV Person. In the absence of the PV Lead, the role may manage day-to-day PV activities under appropriate supervision.
Key Responsibilities:
Local Pharmacovigilance Operations
Execute local PV processes and activities in collaboration with internal functions and external partners.
Ensure activities are aligned with local legislation and regional/global company procedures.
Support management and negotiation of local PV agreements.
Conduct local due diligence activities.
Support implementation of Post-Approval Safety Monitoring Programs (PSMPs).
Coordinate aggregate safety report submissions.
Conduct local PV training and support communication of safety issues.
Review local initiatives for compliance with PV requirements.
Adverse Event Case Management
Manage day-to-day adverse event processing activities.
Perform case intake, translations, acknowledgments, follow-up, and submission in line with PV procedures and country regulations.
Compliance, Quality, and Inspection Readiness
Support local PV, business partner, and vendor audits and inspections.
Contribute to inspection readiness and development of CAPAs for findings and observations.
Participate in issue management and compliance activities, including local corrective actions.
Conduct or support PV self-inspections where applicable.
Support implementation of business continuity plans.
File, store, and archive safety-related documentation according to company and local requirements.
Documentation and Procedural Support
Assist in developing and maintaining local PV procedures and controlled documents.
Maintain documentation such as SOPs, training materials, and controlled PV documents, including the Company Core Pharmacovigilance Document where applicable.
Coordinate or complete translations of PV documents and ensure QC review by a second person where required.
Risk Management and Safety Surveillance
Prepare, maintain, and submit local Risk Management Plans (RMPs) where applicable.
Ensure implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally.
Manage and perform local literature screening and assessment as required.
Monitor Health Authority websites for safety alerts, emerging safety issues, and updated PV requirements where applicable.
Cross-functional Collaboration
Liaise with local business units to provide updates on safety activities and support strategic decisions.
Represent PV in cross-functional forums and alliance partner meetings as needed.
Participate in local committees and councils impacting PV.
Engage in external industry forums and interactions with regulatory authorities where applicable.
Leadership and Development
May manage direct reports, including recruitment, training, development, and performance management.
Support PV Lead with maintenance of the local PV training matrix and onboarding plans.
Participate in special projects or rotational assignments within or outside IPV for professional development.
Complete all required training on time and before performing assigned activities.
Qualifications:
Degree in health, life sciences, or medical sciences, or equivalent through education/experience.
Minimum 2 years of experience in the pharmaceutical industry preferred.
Supervisory experience preferred if the role includes management of staff.
Strong knowledge of adverse event reporting requirements, relevant PV regulations, PV quality management systems, and PV processes.
Experience with PV audits and/or Health Authority inspections preferred.
Skills and Competencies:
Fluent in English, written and spoken; proficient in local language.
Ability to travel regionally and globally.
Strong interpersonal, organizational, and presentation skills.
Ability to collaborate effectively across functions and with external stakeholders.
Advanced negotiation and influencing skills.
Ability to work independently with minimal supervision, except in complex situations.
Demonstrated ability to drive process improvements and change.
Strong strategic thinking, prioritization, and project management skills.
What We Offer:
A maternity leave cover position with the possibility of annual contract renewal.
An expected contract duration until Spring 2029.
The opportunity to work in a highly collaborative and international environment.
A role with broad exposure to pharmacovigilance activities across local, regional, and global levels.
Opportunities to build expertise in PV compliance, safety operations, and cross-functional collaboration.
The chance to contribute to process improvement, quality enhancement, and patient safety.
A supportive team environment with opportunities for professional development and participation in special projects or rotational assignments .
Required Skills:
Drug Development, Drug Safety Surveillance, Pharmaceutical Regulatory Compliance, Pharmacokinetics, Pharmacology, Pharmacovigilance
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/30/2026
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