Safety Manager

Pfizer; Hokksund; Ibrido; NOK 900.000 - 1.200.000; Tempo pieno

Descrizione del lavoro

Pfizer is seeking a pharmacovigilance specialist to monitor safety programs for drugs, biologics, and medical devices. You will evaluate adverse events, support clinical trials, and ensure regulatory compliance across regions.

The role requires strong data management skills, understanding of global reporting requirements, and collaboration with cross-functional teams. Hybrid work location applies, with focus on safety evaluation and reporting activities.

Competenze

• Experience in pharmacovigilance, data management, or clinical/research settings.
• Strong understanding of pharmaceutical development and regulatory aspects.
• Familiarity with international reporting requirements.
• Excellent organizational and time management skills to meet regulatory goals.
• Ability to solve problems and make decisions in complex situations.
• Proficiency with relational databases and data systems.
• Fluency in spoken and written English.
• Fluency in spoken and written Norwegian.

Mansioni

• Monitor and manage the company’s drug, biologics, and medical devices surveillance program.
• Support clinical trials and post-marketing activities for compliance and safety.
• Guide operational teams in project management and resource forecasting.
• Lead or co-lead moderately complex projects and mentor team members.
• Develop and maintain expertise in products, policies, and safety databases.
• Collaborate with internal and external stakeholders on safety activities.

Conoscenze

Pharmacovigilance

Regulatory compliance

Adverse event reporting

Project management

Cross-functional collaboration

Data management

English proficiency

Norwegian proficiency

Formazione

BA/BS in a relevant field

MBA/MS in a related field

PhD/JD (optional seniority)

Associates degree with extensive experience

Descrizione del lavoro

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.

What You Will Achieve

• 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
• Fluency in spoken and written Norwegian

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
• 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

Work Location

Assignment: Hybrid

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career.

Your journey with Pfizer starts here! 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 Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.