Job Description

Summary of Position:

The Pharmacovigilance (PV) Specialist - Regional DPOC LATAM participates in activities of Designated Point of Contact (DPOC) for all countries of Latin America Region.

DPOC is responsible to receive, process, document and route all Product Complaints (which includes Adverse Event; Product Quality Complaint; Counterfeit, Diversion and Tampering) to respective groups (Global Pharmacovigilance, Animal Health and Global Security Group), according to standard procedures within pre-established timeframes.

Deputy PV Coordinator in all DPOC activities whenever is necessary.

Able to function independently in the processing of adverse events. The position reports to PV Coordinator - Regional DPOC LATAM.

Major activities and responsibilities:

• Perform collection, translation and follow-ups of adverse events and product quality complaints associated with the products and report to Global Pharmacovigilance or factory Team in a timely manner with high quality for Latin America region;

• Report suspect of tampering, counterfeiting and diversion to Global Security Group;

• Oversight of Local Literature Search related activities;

• Responsible for the filing, storage and archiving of safety-related data in accordance with company policies and local requirements;

• Support countries in Contract Management activities;

• Oversight of compliance with PV requirements in Post Authorization Studies, Marketing Support Studies and support the countries in implementation of PV tasks related to these activities.

Organizational structure:

The PV Specialist - Regional DPOC LATAM has a direct reporting relationship to Regional PV Coordinator Latin America.

Qualifications

Background Requirements

• The incumbent must have a health, life science, or veterinary medicine degree or equivalent by education.

• Pharmaceutical industry experience.

• Pharmacovigilance regulations within assigned country(ies) if applicable.

• The PV Specialist - Regional DPOC LATAM is expected to have strong communication and time management skills.

Functional competencies PV Intelligence

• Knowledge of pharmacovigilance systems & requirements

• Knowledge of pharmacovigilance principles, concepts, practices and standards

• Knowledge of the local country(ies) pharmacovigilance regulations and obligations.

Skills

Communication skills

• Excellent written & spoken Spanish and English

• Ability to communicate effectively verbally and in writing

• Proficient in local language(s)

• Proficient in Good Documentation Practices

Computer skills

• Good word processing, presentation & spreadsheet application skills

• Knowledge about the use of a safety database

• Ability to learn new computer interface systems

• Strong project management skills with the ability to prioritize assignments

• Excellent time management, organizational & planning skills

• High level of accuracy & quality in work

• Strong collaboration skills with the ability to work across boundaries

• Sense of urgency and the ability to make rapid, disciplined decisions

• Compliance mindset/focused

• Courage and candor

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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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adverse Drug Reaction (ADR) Monitoring, Adverse Drug Reaction (ADR) Monitoring, Applied Engineering, Clinical Trial Oversight, Communication, Compliance Investigations, Compliance Program Development, Contract Management, Data Quality Assurance, Detail-Oriented, Drug Safety Surveillance, Employee Training Programs, Management Process, Organizational Structures, Periodic Safety Update Reports, Pharmaceutical Management, Pharmacokinetics, Pharmacovigilance, Post Marketing Surveillance, Project Management, Regulatory Communications, Regulatory Compliance Audits, Regulatory Reporting, Regulatory Writing, Stakeholder Communications {+ 2 more}

 Preferred Skills:

Job Posting End Date:

05/23/2025

*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.