Deputy EU QPPV (m/f/d)

DE71 (FCRS = DE071) HEXAL AG; Holzkirchen; Hybride; EUR 91 000 - 169 000; Plein temps

Avantages offerts par ce poste

30 vacation days

Vacation payment €1,200

Capital-forming benefits €40/mo

Company pension

Flex-hybrid 50% in-office

Skillsoft & Learnlight access

OurShare

Résumé du poste

Sandoz in Holzkirchen, Germany is seeking a Deputy EU QPPV to oversee pharmacovigilance activities during designated absences. You will ensure training continuity, coordinate regulatory responses, and support the global PV system governance.

We expect substantial PV experience, strong knowledge of EU safety legislation, and the ability to work cross-functionally with Medical, Regulatory, and Quality teams. The role includes a 50% flex-hybrid schedule and a competitive compensation package.

Qualifications

• Minimum: Degree in medicine, pharmacy, life sciences, or another relevant healthcare or scientific discipline.
• Substantial experience in pharmacovigilance or drug safety, with senior PV responsibilities.
• Strong knowledge of EU pharmacovigilance legislation and GVP.

Responsabilités

• Act as the formally designated Deputy EU QPPV during agreed periods of absence and perform delegated QPPV activities.
• Support continuous availability of an appropriately trained QPPV or deputy contact for EU/EEA authorities and coordinate responses.
• Maintain oversight of the global pharmacovigilance system, including outsourced activities.
• Monitor product safety profiles and regulatory obligations related to MAHs and risk minimisation.
• Oversee PV activities like case management, signal management, and aggregate reporting.
• Participate in safety governance forums and provide QPPV input on safety decisions.
• Support maintenance of the PV System Master File and documentation of oversight and decisions.
• Monitor compliance metrics, deviations, CAPAs, and audit findings with escalation to EU QPPV.

Connaissances

Clinical Trials

Functional Teams

Literature Review

Management Skills

Medical Information

Medical Records

Medical Strategy

Pharmacovigilance

Regulatory Compliance

Risk Management

Safety Science

Formation

Medical degree / life sciences

Description du poste

Job Description Summary To support the EU QPPV in maintaining continuous oversight of the pharmacovigilance system and product benefit-risk profiles, and to act on behalf of the EU QPPV during formally designated periods of absence within the documented scope of delegation. Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities:

• Act as the formally designated Deputy EU QPPV during agreed periods of absence and perform delegated QPPV activities in accordance with applicable legislation, GVP requirements, and internal procedures.
• Support continuous availability of an appropriately trained QPPV or deputy contact for EU/EEA competent authorities and coordinate timely responses to pharmacovigilance-related requests.
• Support the EU QPPV in maintaining oversight of the structure, performance, and quality of the global pharmacovigilance system, including outsourced and delegated activities.
• Maintain appropriate awareness of product safety profiles, emerging safety concerns, and conditions or obligations associated with marketing authorisations and risk-minimisation measures.
• Support oversight of key pharmacovigilance activities, including case management, signal management, aggregate reporting, risk management, safety variations, partner interfaces, and regulatory commitments.
• Participate in safety governance forums and provide QPPV input to significant safety decisions, benefit-risk evaluations, and proposed regulatory actions.
• Support maintenance of the Pharmacovigilance System Master File and ensure that QPPV oversight, decisions, delegation, and supporting evidence are appropriately documented.
• Monitor relevant compliance metrics, KPIs and KQIs, deviations, CAPAs, audit and inspection findings, and ensure significant risks are escalated promptly to the EU QPPV and appropriate governance bodies.
• Contribute to pharmacovigilance inspection readiness and participate in regulatory inspections and internal or external audits, including oversight of timely and effective remediation.
• Provide expert pharmacovigilance advice and collaborate with Patient Safety, Medical, Regulatory Affairs, Quality Assurance, Clinical Development, Commercial, Legal, and other relevant functions.
• Support development and maintenance of QPPV Office procedures, business continuity and coverage arrangements, governance processes, and relevant training.
• Coach and mentor colleagues supporting QPPV activities and promote a strong culture of patient safety, quality, transparency, and regulatory compliance.

What you’ll bring to the role:

Essential Requirements:

• Minimum: Degree in medicine, pharmacy, life sciences, or another relevant healthcare or scientific discipline.
• Substantial experience in pharmacovigilance or drug safety, including senior responsibility for PV compliance, safety governance, or system oversight.
• Strong knowledge of EU pharmacovigilance legislation, Good Pharmacovigilance Practices, and relevant international safety requirements.
• Broad understanding of benefit-risk evaluation, signal management, risk management, aggregate reporting, case processing, quality systems, audits, and inspections.
• Prior QPPV, Deputy QPPV, local QPPV, or equivalent senior pharmacovigilance experience is desirable.
• Demonstrated ability to influence cross-functional stakeholders and make risk-based decisions in a complex regulated environment.
• Strong scientific judgment, integrity, accountability, communication, collaboration, and effective escalation skills.
• Ability to operate calmly and effectively under time-critical conditions with strong attention to detail.
• English: fluent written and spoken.
• Additional languages are an advantage.

Compensation Structure & Criteria:

Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.

Job location:

Holzkirchen, Germany

Starting pay range:

EUR 90,700 - 168,500

Variable compensation:

15% performance-based bonus

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!

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. If you would like to request this, please let us know in advance as a note on your CV.

Skills Desired

• Clinical Trials
• Functional Teams
• Literature Review
• Management Skills
• Medical Information
• Medical Records
• Medical Strategy
• Pharmacovigilance
• Regulatory Compliance
• Risk Management
• 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 have an ambition 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!