Senior Director, Global Patient Safety Science

Chiesi Group; Cape Town; Hybrid; ZAR 400 000 - 500 000; Full time

Job summary

A leading global pharmaceutical company is seeking a Senior Director, Global Patient Safety Science. This role is critical for managing the patient safety strategy and operations across its global portfolio. Candidates must have over 10 years of experience in global medical safety and pharmacovigilance, demonstrating skills in team leadership and regulatory compliance. The position offers a collaborative environment with a focus on improved patient safety and risk management strategy implementation.

Benefits

Flexible working approach

Remote working options

Continuous training and development

Support for relocation

Tax assistance for foreign colleagues

Qualifications

• 10+ years in global medical safety or pharmacovigilance in pharma/biotech.
• Proven leadership experience in patient safety.
• Advanced knowledge of PV regulations and health authority expectations.

Responsibilities

• Lead Patient Safety Science team for safety surveillance.
• Oversee patient safety assessments in clinical development.
• Collaborate with cross-functional teams and external partners.

Skills

Relationship building

Collaboration

Strategic vision

Ethical mindset

Patient safety focus

Education

Medical degree (MD)

Job description

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to have been awarded withB Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

Purpose

The Senior Director, Global Patient Safety Science leads the patient safety strategy and operations across Chiesi’s global portfolio, ensuring continuous monitoring of product safety, proactive risk management, and regulatory compliance. This role involves cross-functional collaboration, leadership of a dedicated safety team, and direct engagement with internal and external stakeholders, including health authorities and commercial partners. The position plays a critical role in clinical development, due diligence, and post-marketing safety activities.

He/She reports to the Vice President, Global Regulatory Affairs and Patient Safety.

Main Responsibilities

• Lead the Patient Safety Science team of product assigned patient safety physicians, supporting them for safety surveillance and risk management activities of their assigned Chiesi products.
• Ensure up-to-date oversight of the emerging safety profile for all Chiesi products and the corresponding safety and risk management strategies.
• Provide strategic medical and scientific leadership for patient safety across Chiesi’s product portfolio.
• Oversee patient safety assessments during due diligence, clinical development, and post-marketing phases.
• Ensure the delivery of Patient Safety Science activities including support of clinical trials, delivery of aggregate reports, signal detection, signal assessment and safety signal management, safety risk mitigation activities and the appropriate communication of safety messaging across internal and external stakeholders.
• Guide the preparation and maintenance of regulatory safety documents (e.g., RMPs, PSURs, DSURs).
• Represent Patient Safety in internal and external meetings, including interactions with Health Authorities.
• Collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory Affairs, and external partners.
• In collaboration with the QPPV, ensure compliance with health authority requirements and take the lead in assigned areas for inspections and audits and implement appropriate remediation where required.
• Active member of the GRAPS Leadership Team and contribute to the Regulatory Affairs and Patient Safety vision

Experience Required

• At least 10 years of experience in global medical safety / pharmacovigilance roles in a global pharmaceutical/biotech company, working with development programs, , regulatory submissions and post-marketing safety surveillance
• Proven team leadership and line management experience and skills within a patient safety or similar setting.
• Advanced knowledge of PV regulations, Health Authority expectations and cross-functional/organizational working, particularly in due diligence, partnerships and clinical development.
• Diverse experience across pharmacovigilance, including systems, operations and safety science at global and local levels, for different types of products (small molecules, biologics, combination products)

Education

Medical degree (MD)

Languages

Excellent command of English (spoken and written).

Skills required

• Relationship builder both internally and externally, a strong collaborator within the GRAPS function, the wider organisation, and externally (e.g. partner companies, service providers, academic partners)
• Strong ethical sense combined with quality and patient safety mindset
• Strategic vision and ability to work with a team to successfully deliver.

Location

The position can be based in one of our affiliates in Europe

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.