Safety Officer

Pfizer; Bogotá, Distrito Capital; Presencial; COP 156.905.000 - 235.359.000; Jornada completa

Descripción de la vacante

A global pharmaceutical leader in Bogotá is seeking a Medical Safety Associate to monitor drug surveillance programs and support clinical trials. Candidates should possess a BA/BS and at least 4 years of experience in pharmacovigilance. This role offers an opportunity to contribute to safety evaluations and regulatory compliance in a dynamic healthcare environment.

Formación

• 4+ years of experience in pharmacovigilance or related field.
• Fluency in English (written and spoken) is required.
• Organizational skills to meet regulatory goals are essential.

Responsabilidades

• Monitor and manage compliance of drug surveillance programs.
• Support clinical trials and ensure safety compliance.
• Oversee Country Quality Plan and manage team resources.

Conocimientos

Pharmacovigilance

Data management

Critical thinking

Project management

Regulatory knowledge

Educación

BA/BS degree or equivalent

Herramientas

Relational databases

Descripción del empleo

Use Your Power for Purpose

At Pfizer, our Worldwide Medical and Safety colleagues are essential in bridging evidence-based medical decision support with colleagues and stakeholders to achieve better health and treatment outcomes. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically necessary expertise, or investigating ways to close data gaps, our mission remains clear. We aim to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

Overview

What You Will Achieve

In this role, you will:

• Monitor and manage the company's drug, biologics, and medical devices surveillance program, including adverse report intake, evaluation, and processing.
• Support clinical trials and post-marketing activities, ensuring compliance and safety.
• Guide operational teams in project management, forecasting resource needs, and identifying improvement areas in products, processes, or services.
• Lead or co-lead moderately complex projects, managing time and resources effectively, and provide guidance to teams.
• Apply discipline knowledge to contribute to departmental work, making decisions to resolve moderately complex problems and developing new options.
• Work independently on assignments, seeking guidance on unusual or complex problems, and review your own work and that of colleagues in a mentor role.
• Oversee the development and maintenance of the Country Quality Plan and guide colleagues on adverse event report processing.
• Collaborate with internal and external stakeholders to support local safety activities and act as a Business Management Subject Matter Expert for Safety Evaluation and Reporting (SER).
• Manage safety team resources, ensure the completion of safety-related reports, and support audits, regulatory inspections, and related requests.
• Develop and maintain expertise in assigned products, corporate policies, local regulations, and safety database functions, applying judgment and leadership to ensure continuous inspection readiness.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
• Experience in pharmacovigilance, data management, clinical care, or scientific research
• Deep understanding of the pharmaceutical business, including drug development and regulatory aspects
• Familiarity with international regulations and worldwide reporting requirements
• Strong organizational and time management skills to meet strict regulatory compliance goals
• Ability to solve problems and make decisions in complex situations
• Proficiency in computer literacy, especially in managing relational databases
• Fluency in spoken and written English

Bonus Points If You Have (Preferred Requirements)

• Master's degree
• Relevant pharmaceutical industry experience
• Managerial experience in hospital or pharmacy and familiarity with clinical assessment
• Knowledge of training design and tools and experience in applying training methodology
• Ability to work collaboratively with cross-functional teams
• Strong analytical and problem-solving skills

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.