Clinical Safety Physician/Manager

Angelini Pharma; Roma; In loco; EUR 120.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equal opportunity employer

Descrizione del lavoro

Angelini Pharma seeks a Global Clinical Safety Physician to lead pharmacovigilance across global programs and ensure regulatory compliance. The role reports to the Global Patient Safety Head and collaborates with Regulatory, Medical Affairs and Development teams to safeguard patients and set safety strategy.

Ideal candidates have 5+ years in pharma safety, strong ICH knowledge, and excellent leadership and communication skills to influence portfolio decisions within a fast-paced matrixed

Competenze

• Minimum 5+ years in the pharmaceutical industry or clinical care setting.
• Experience in neuroscience or rare disease is a plus.
• Knowledge of drug development process.
• Direct experience with global regulatory filing and interactions with major regulatory agencies (e.g., FDA advisory committees).
• Expertise in pharmacovigilance with regulatory requirements and guidelines.

Mansioni

• Provide GPS Medical leadership and ensure proactive pharmacovigilance for assigned product(s).
• Demonstrate advanced knowledge of safety concepts per ICH, US, and international guidelines and GxP.
• Synthesize complex data into actionable insights and translate issues into strategic discussions.
• Build relationships with stakeholders, representing safety in the organization.
• Represent GPS Medical in inspections and audits.
• Foster a collaborative environment focused on inclusion, innovation, acceleration, and delivery.
• Provide training, coaching and mentorship to team members.
• Ensure compliance with corporate policies and training curriculum.

Conoscenze

Analytical skills

Epidemiology

Statistics

English fluency

Interpersonal skills

Negotiation

Cross-functional collaboration

Problem solving

Multi-project management

Ethics & compliance

Formazione

MD (Medicine)

PhD preferred

Descrizione del lavoro

The Global Clinical Safety Physician is a the senior clinical safety expert and reports directly to the Global Patient Safety Head. The Global Patient Safety Manager is responsible for developing, managing, executing, and overseeing all aspects of the safety programmes for one (or more) pipeline asset(s) throughout the product(s') life cycle. GPSM plays a key role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnerships with the integrated development or product team to deliver on these safety commitments, while also demonstrating GPS expertise and leadership.

Key Responsibilities Include:

• Provide GPS Medical leadership and ensure proactive pharmacovigilance for assigned product(s)
• Demonstrate advanced knowledge of safety concepts, per ICH, US, and international regulation/guidelines and GxP.
• Synthesize complex data into actionable insights and translate technical issues into strategic discussions.
• Build strong relationships with key stakeholders, representing and championing the role of safety in the organization.
• Represent GPS Medical in inspections and audit activities.
• Foster and support a collaborative working environment focused on inclusion, innovation, acceleration, and delivery.
• Provide training, coaching, and mentor.
• Experience and knowledge sharing to further advance the goals of the GPS group and wider enterprise.
• Maintain compliance with corporate policies and relevant training curriculum.

Education:

• Degree in Medicine; PhD (or other complementary degree) in scientific discipline is preferred.

Experience:

• Minimum 5+ years’ experience in the pharmaceutical industry or clinical care setting.
• Experience in neuroscience or rare disease area is a plus.
• Knowledge of drug development process
• Direct experience with global regulatory filing and interacting with major regulatory agencies e.g., FDA advisory Committees, Scientific Advice, etc.
• Expertise in pharmacovigilance with deep knowledge of regulatory requirements and guidelines pertaining to drug safety.
• Thorough knowledge and understanding of safety, including clinical safety, deliverables, standards, and processes at a global level; including pre and post launch experience.
• Proven record of successful clinical safety delivery with demonstrated examples of strategic influence to portfolio/clinical studies/programs.
• Demonstrated success in implementing projects and/or innovating.

Skills, Knowledge & Abilities

• Strong analytical skills with the ability to critically interpret and apply scientific and clinical data for risk assessment and management.
• Proficient understanding of epidemiology and statistics, with the ability to apply data-driven decision-making.
• Fluent in English with highly effective written and verbal communication skills
• Excellent interpersonal, organizational and negotiation skills
• Receptive, engaging, and impactful contributor
• Ability to thrive in a matrixed environment, effectively collaborating across cross-functional teams including Regulatory, Clinical Development, Medical Affairs, Commercial, and Quality.
• Strong problem-solving and critical thinking abilities, with a demonstrated ability to manage complex issues and competing priorities.
• Ability to work on multiple projects and function effectively in a fast-paced matrixed environment.
• Commitment to business ethics and compliance, ensuring alignment with corporate values, industry regulations, and best practices.

Angelini Pharma is an equal Opportunity Employe

We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment.