Drug Safety Specialist (Temporary)

Job Description

The Pharmacovigilance Associate Specialist supports regional PV activities across LATAM, with a primary focus on follow‑up (FU) activities, ICSR submissions to Health Authorities, and other regional PV support activities as required. Under the oversight of the PV Manager or a designated PV colleague, the role contributes to the execution of day‑to‑day PV processes, ensuring compliance with local regulations and global/company procedures.

This position offers exposure to regional PV operations, case management, regulatory interactions, compliance activities, and cross‑functional collaboration, making it an excellent development opportunity for early‑career professionals in Pharmacovigilance.

• Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.

• Activities may include but are not limited to management of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and submitting aggregate safety reports.

• Assists with day-to-day adverse events case management which may include case intake (where needed), translations (English and/or local language, (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.

• Supports local PV audits and inspections when requested.

• Participates in issue management/compliance activities and assists in coordinating/preparing the necessary local corrective actions.

• Supports development and maintenance of local PV procedures and controlled documents.

• Supports PV self-inspections as required by PV Legislations (where applicable).

• Supports appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per local procedure and local legislations.

• May be 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.

• Translates or QCs translation of applicable PV documents.

• Responsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.

• 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.

Requirements

Education:

• Health, life science, or medical science degree or equivalent by education/experience

Work Experience:

• 1 year of experience in Pharmacovigilance or the pharmaceutical industry

• General knowledge of AE reporting requirements and relevant PV regulations

•  English Advanced (written and spoken)

• Good communication, organizational, and time management skills 

• Preferred: experience using Veeva

Required Skills:

Adverse Event Report, Case Management, Compliance Investigations, Compliance Operations, Compliance Reviews, Cross-Functional Collaboration, Data Analysis, Data Management, Data Processing, Data Quality Assurance, Detail-Oriented, Drug Safety Surveillance, Employee Training Programs, Legal Case Management, Multidisciplinary Collaboration, Periodic Safety Update Reports, Pharmacovigilance, Policy Implementation, Protocol Development, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Management, Regulatory Negotiations, Safety Reporting

Preferred Skills:

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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:

04/27/2026

*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.