Country Safety Lead

Pfizer; Buenos Aires; On-site; ARS 2,400,000 - 3,200,000; Full time

Job summary

Pfizer is seeking a Senior Pharmacovigilance Leader to guide safety surveillance for drugs, biologics, and devices. You will oversee intake, evaluation, and reporting of adverse events while driving process improvements and cross-functional collaboration to meet regulatory standards.

The role requires advanced knowledge of global drug safety regulations, strong leadership, and mentoring abilities. On-site work with strong coordination across clinical, regulatory, and safety teams is expected.

Qualifications

• Bachelor's degree or higher with relevant experience in pharmacovigilance or data management
• Experience in pharmacovigilance and/or clinical care or clinical/scientific research
• Strong knowledge of global regulations for drug development
• Ability to foster teamwork and lead diverse groups

Responsibilities

• Lead the safety surveillance program across drugs, biologics, and devices from intake to reporting
• Drive improvements using insights from internal and external challenges and forecast resource needs
• Provide technical guidance and oversee cross-functional teams on safety activities
• Organize the country safety group and manage recruitment/training of colleagues
• Ensure timely handling of reports to meet regulatory requirements and standardize processes
• Mentor colleagues on using corporate safety databases and risk management practices
• Identify process/product improvements and manage projects within the department

Skills

Leadership

Project management

Cross-functional collaboration

Problem solving

Mentoring

Negotiation

Communication

Education

BA/BS in a relevant field

MBA/MS

PhD/JD

Associate's degree

High School Diploma

Tools

MedDRA

Pharmacovigilance databases

Job description

Use Your Power for Purpose

At Pfizer, our mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Your work will bridge evidence-based medical decision support with colleagues and stakeholders to achieve better health and treatment outcomes. Whether you are developing the framework necessary to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to close data gaps, your impact will be significant. You will help ensure that our medicines are used safely and effectively, making a global impact on patient health.

What You Will Achieve

• Lead the company's drug, biologics, and medical devices surveillance program, including intake, evaluation, and processing of adverse reports, supporting both clinical trials and post-marketing activities.
• Drive improvements in products, processes, and services by leveraging extensive knowledge of internal and external business challenges, and lead projects to meet objectives and prepare forecasts for resource requirements.
• Provide technical guidance and oversight to team members, playing a crucial role in problem-solving, and manage multiple projects and ongoing work activities involving cross-functional representatives.
• Organize and manage the country safety group to ensure effective coverage of safety-related activities, including monitoring and managing recruitment and training of colleagues.
• Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements and provide guidance for standardization of processes and goals.
• Mentor colleagues on the effective use of the corporate safety database, leveraging required judgment, issue resolution, and negotiation skills necessary for leadership roles.
• Analyze and monitor activities, define and implement corrective actions where applicable, and lead people, technology, and financial resources within the department.
• Share knowledge actively within the department, identify potential improvements in processes or products, and take risks to develop innovative ideas.
• Solve moderately complex problems within own area of expertise, assist with problems outside the department, and oversee operational activities to support short-term goals.
• Recognize the need for development in others, collaborate to create development plans, manage the performance of direct reports through goal setting, coaching, and ongoing assessment, and effectively communicate complex concepts and persuade others to adopt a point of view.

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
• Demonstrated experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research
• Good knowledge of global regulations and guidelines for drug development
• Demonstrated ability to foster teamwork
• Experience and skill with medical writing
• Good understanding of medical terminology
• Good problem-solving and decision-making skills

Bonus Points If You Have (Preferred Requirements)

• Master's degree
• Relevant pharmaceutical industry experience
• Ability to make decisions independently in both routine case processing and unique and/or complex situations
• Ability to manage multiple priorities and projects simultaneously
• Strong analytical and organizational skills
• Experience managing Direct reports
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Last date to apply for job: Oct 2nd

Work Location Assignment: On-site 2-3x/week or as needed by the business

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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Medical