Job Description:

An amazing opportunity has arisen for a Pharmacovigilance (PV) Country Lead Portugal (Associate Director). In this role, you will be responsible for a range of assigned PV activities and will be empowered to work and make decisions independently within your delegated remit. You will ensure that all PV activities under your oversight are executed in accordance with applicable regulations, local legislation, and internal company policies and procedures.

In this role, you will be designated Local PV Contact / Local Responsible PV person, as required by local PV legislation. You will work closely with internal and external stakeholders and lead a team who reports into you. In your role you will be reporting into the PV Cluster Lead Mid-Europe.

What you will do

Bring energy, knowledge, innovation and leadership to carry out the following:

• Oversee and execute local PV processes and activities in collaboration with internal functions and external partners, ensuring alignment with local legislation and local/regional/global procedures, including management of local PV agreements, due diligence, PSMP implementation, training and safety communication.
• Lead day‑to‑day adverse event case management (e.g., case triage, translations, follow‑up) in accordance with PV procedures and country regulations, and act as local PV subject matter expert on relevant regulations, processes and procedures.
• Support audits and inspections (local PV, business partner and vendor), including readiness activities, participation in issue management/compliance activities and contribution to CAPA development and local corrective actions.
• Develop, maintain and implement local PV procedures and controlled documents (e.g., SOPs, training materials, Pharmacovigilance Documents, local RMPs), and oversee local literature screening, risk management activities and business continuity plans in line with company and regulatory requirements.
• Monitor Health Authority websites for safety issues, alerts and PV requirements; liaise with local business units; represent PV in cross‑functional and external forums; participate in local committees/councils and special projects; and, where applicable, manage direct reports including recruitment, development and performance management.
• Manage and develop the local PV team.

What skills you will need

In order to excel in this role, you will more than likely have:

• Language skills: native in Portuguese and excellent in English (both written and verbal)
• Solid experience in pharmacovigilance within the pharmaceutical or biotechnology industry, with proven responsibility for local PV activities.
• Strong knowledge of local PV legislation, regulations and guidelines, and demonstrated ability to interpret and operationalize PV requirements.
• Hands‑on expertise in adverse event case management, aggregate safety reporting, risk management (including RMPs and Risk Minimization Measures) and local literature surveillance.
• Experience supporting or leading PV audits and inspections, including preparation, conduct, issue management and development/implementation of CAPAs.
• Proven ability to develop, implement and maintain PV procedures and controlled documents, and to ensure high‑quality PV data and documentation.
• Strong collaboration and communication skills, with the ability to work effectively with cross‑functional teams, business partners, vendors, Health Authorities and external industry forums.
• Demonstrated organizational and project management skills, with the ability to manage multiple priorities, special projects and business continuity activities in a fast‑paced environment.
• Commitment to continuous learning, completion of required trainings, and high standards of compliance, integrity and accountability in all PV activities.

Why Join Us? We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing talented, and committed people together. The fastest way to breakthrough innovation is when varied ideas come together in an inclusive environment.

So, if you are ready to...

…contribute your pharmacovigilance expertise, leadership and passion for patient safety in a highly visible Associate Director role, please apply today.

Required Skills:

Accountability, Accountability, Adaptability, Adverse Event Report, Auditing, Audit Inspections, Business Continuity, Collection Systems, Communication, Compliance Monitoring, Data Management, Global Program Development, Issue Management, Leadership, Legal Archiving, Management Process, Organizational Performance Management, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Process Improvements, Regulatory Compliance, Regulatory Compliance Consulting, Regulatory Reporting, Risk Minimization, Strategic Planning {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE:

Search 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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/4/2026

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