Patient Safety Specialist (d/f/m)

DE71 (FCRS = DE071) HEXAL AG; Holzkirchen; Hybrid; EUR 56,000 - 104,000; Full time

Benefits offered by this job

30 vacation days

Vacation pay 1,200€

Capital-forming benefits 40€ / month

Company pension

Flex-hybrid 50% in office

Learning platforms Skillsoft & Learnl

Employee share program OurShare

Job summary

Sandoz is seeking a Deputy Responsible Person for Pharmacovigilance Switzerland to strengthen patient safety and regulatory compliance across the Swiss affiliate. You will oversee safety activities, support local PV processes, and collaborate with cross-functional teams across Europe.

The role requires Swiss language fluency and English proficiency, with 2+ years in PV or regulatory affairs. The position offers a hybrid setup with competitive benefits and growth opportunities within a global

Qualifications

• Bachelor’s Degree in a Health Care Sciences discipline (e.g., Medicine, Nursing, Pharmacy) or an equivalent combination of education, training, and relevant professional experience.
• Fluency (minimum C1 level) in at least one Swiss official language (German, French, or Italian) is required.
• Fluency in English, both written and spoken; additional language skills are an advantage.
• Minimum 2 years of experience in Pharmacovigilance, Drug Safety, Medical Affairs, Regulatory Affairs, or a related function within the pharmaceutical industry.
• Relevant pharmacovigilance experience, supported by training and/or demonstrated expertise in EU and/or Swiss PV regulations.
• Good understanding of Swiss pharmacovigilance legislation and medicinal product safety requirements.
• Strong knowledge of medical and pharmacological terminology.
• Excellent communication, organizational, and stakeholder management skills, with the ability to collaborate effectively across cross-functional and multicultural teams.
• Quality-focused and compliance-driven mindset, with experience supporting audits, inspections, deviations, CAPAs, and continuous improvement initiatives considered an advantage.

Responsibilities

• Support the Senior Manager Patient Safety in the coordination and execution of patient safety and pharmacovigilance activities within the Swiss affiliate.
• Act as Deputy Responsible Person for Pharmacovigilance Switzerland and provide support for local pharmacovigilance oversight activities in accordance with Swiss regulatory requirements.
• Promote understanding of the pharmacovigilance system across the Swiss affiliate and support adherence to local safety requirements, including implementation and tracking of Risk Management Plan (RMP) commitments and risk minimization activities.
• Support the effective, accurate, and timely flow of safety-relevant information within the Swiss affiliate and between business partners, regional hubs, and third-party vendors, escalating issues as appropriate.
• Maintain awareness of the safety profiles of Sandoz products and provide patient safety support for marketed and investigational products, including response to safety-related requests and implementation of relevant safety measures.
• Participate in the oversight of pharmacovigilance activities, including case management, periodic reporting, local safety programs, and activities outsourced to third-party vendors.
• Support the maintenance of local pharmacovigilance processes, documentation, and quality systems in accordance with applicable regulatory requirements and company procedures.
• Support patient safety training, Business Continuity Planning (BCP), and cross-functional initiatives to ensure awareness of pharmacovigilance responsibilities across the organization.
• Contribute to compliance management, regulatory intelligence, audit and inspection readiness, deviation and CAPA activities, and other continuous improvement initiatives related to the Pharmacovigilance System.

Skills

Regulatory affairs

Pharmacovigilance

Communication skills

Organizational skills

Stakeholder management

English proficiency

Swiss health language proficiency

Education

Bachelor’s Degree in Health Care Sciences

Job description

Job Description Summary This is an exciting opportunity to become a key member of the Swiss Patient Safety team and to serve as Deputy Responsible Person for Pharmacovigilance Switzerland. In this highly visible role, you will contribute directly to patient safety, regulatory compliance, and the continuous development of the Swiss pharmacovigilance system while collaborating with colleagues across Europe and beyond. As a Patient Safety Specialist, based in either Holzkirchen, Germany or Vienna, Austria, you will work closely with the Senior Manager Patient Safety Switzerland. You will support the implementation and oversight of pharmacovigilance activities within the Swiss affiliate, helping to ensure compliance with local and global patient safety requirements. Working closely with cross-functional teams, regional stakeholders, and external partners, you will contribute to the monitoring of product safety, risk management activities, quality processes, and continuous improvement initiatives to support the safe and effective use of medicines. This role offers excellent opportunities for professional growth and development within a dynamic international environment.

Your Key Responsibilities

Your responsibilities include, but are not limited to: Support the Senior Manager Patient Safety in the coordination and execution of patient safety and pharmacovigilance activities within the Swiss affiliate. Act as Deputy Responsible Person for Pharmacovigilance Switzerland and provide support for local pharmacovigilance oversight activities in accordance with Swiss regulatory requirements. Promote understanding of the pharmacovigilance system across the Swiss affiliate and support adherence to local safety requirements, including implementation and tracking of Risk Management Plan (RMP) commitments and risk minimization activities. Support the effective, accurate, and timely flow of safety-relevant information within the Swiss affiliate and between business partners, regional hubs, and third-party vendors, escalating issues as appropriate. Maintain awareness of the safety profiles of Sandoz products and provide patient safety support for marketed and investigational products, including response to safety-related requests and implementation of relevant safety measures. Participate in the oversight of pharmacovigilance activities, including case management, periodic reporting, local safety programs, and activities outsourced to third-party vendors. Support the maintenance of local pharmacovigilance processes, documentation, and quality systems in accordance with applicable regulatory requirements and company procedures. Support patient safety training, Business Continuity Planning (BCP), and cross-functional initiatives to ensure awareness of pharmacovigilance responsibilities across the organization. Contribute to compliance management, regulatory intelligence, audit and inspection readiness, deviation and CAPA activities, and other continuous improvement initiatives related to the Pharmacovigilance System.

What you’ll bring to the role

• Bachelor’s Degree in a Health Care Sciences discipline (e.g., Medicine, Nursing, Pharmacy) or an equivalent combination of education, training, and relevant professional experience.
• Fluency (minimum C1 level) in at least one Swiss official language (German, French, or Italian) is required.
• Fluency in English, both written and spoken; additional language skills are an advantage.
• Minimum 2 years of experience in Pharmacovigilance, Drug Safety, Medical Affairs, Regulatory Affairs, or a related function within the pharmaceutical industry.
• Relevant pharmacovigilance experience, supported by training and/or demonstrated expertise in EU and/or Swiss PV regulations.
• Good understanding of Swiss pharmacovigilance legislation and medicinal product safety requirements.
• Strong knowledge of medical and pharmacological terminology.
• Excellent communication, organizational, and stakeholder management skills, with the ability to collaborate effectively across cross-functional and multicultural teams.
• Quality-focused and compliance-driven mindset, with experience supporting audits, inspections, deviations, CAPAs, and continuous improvement initiatives considered an advantage.

Compensation Structure & Criteria

Job location: Holzkirchen, Germany

Starting pay range: EUR 56,000 - 104,000

Variable compensation: 10% performance-based bonus, performance based long-term incentive plan.

Additional benefits include:

• 30 vacation days per year (in full time)
• 1.200€ vacation payment (in full time)
• €40/month in capital-forming benefits (in full time)
• company pension
• flex-hybrid working 50% per week in the office
• access to our learning & development platforms Skillsoft & Learnlight
• Access to our employee share program “OurShare”

Pay frequency: Monthly

Expected weekly working hours: 40 hours

Contract type: full time

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process.

Skills Desired

• Databases
• Employee Training
• Filing Documents
• Pharmacovigilance
• Reporting
• Safety Science

Our Purpose

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we are ambitious to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!