PV Operations & Compliance Manager

Oncopeptides AB

Sweden - Stockholm

Apply now Be part of a team where trust, courage, and collaboration shape the future of patient safety.
Bringing Hope Through Science
At Oncopeptides, science and innovation are the driving forces behind everything we do. Guided by our values - Science, Trust, Courage, Collaboration, and Passion - committed to bring hope through science and improving the lives of patients around the world.

PharmaRelations is supporting Oncopeptides in seeking a Pharmacovigilance Operations & Compliance Manager / PSMF Lead to join the Global Pharmacovigilance and Patient Safety (PV&PS) team in Stockholm.

This is a key position that ensures excellence in pharmacovigilance operations and compliance. You will take ownership of the EU & UK Pharmacovigilance System Master File (PSMF), oversee PV operations and vendors, and play an active part in shaping digital transformation projects such as Veeva implementation.

Location: Stockholm, Sweden
Employment: Full-time | Hybrid (approx. 3 days/week on-site)

About the Role
As our new PV Operations and Compliance Manager, you will be central in building a sustainable and efficient PV organization. You will combine hands-on operational work with system and process development, ensuring quality, compliance, and readiness for future growth.

You will collaborate closely with cross-functional team as Quality, Clinical, Medical and Commercial and work in an environment that encourages curiosity, initiative, and collaboration.

Key Responsibilities

• Lead daily PV operations and ensure compliance with regulatory requirements.
• Oversee vendor performance and case processing quality.
• Act as Business Process Owner for Oncopeptides’ safety database (Veeva Vault Safety).
• Coordinate and maintain the EU & UK PSMF, ensuring accuracy, traceability, and compliance.
• Drive continuous improvement, digitalization, and process enhancements within PV.
• Support inspections, audits, and compliance reporting.
• Manage PV training, onboarding/offboarding, and system access.
• Support the QPPV and Deputy QPPV with documentation and authority interactions.
• Collaborate in cross-functional projects and mentor colleagues on PV operations topics.

Qualifications and Experience

• Bachelor’s degree (or higher) in life sciences, pharmacy, or a related field.
• 4–6 years of experience in global pharmacovigilance within biotech/pharma (post-marketing).
• Hands-on or oversight experience in case processing.
• Strong knowledge of EU, ICH, and GVP guidelines.
• Experience with PV systems (Veeva Vault Safety is an advantage).
• Excellent coordination, project management, and communication skills.
• Fluent in English, both written and spoken.

Preferred:

• Experience with PSMF coordination or maintenance.
• Experience in clinical development or product lifecycle management.
• Interest in digital systems, data quality, and process optimization.

Who You Are
You are a structured, collaborative, and pragmatic professional who thrives in a dynamic environment. You combine operational excellence with a forward-looking mindset, enjoy improving processes, and bring clarity to complex tasks.

You believe in teamwork, transparency, and the power of science to make a difference and you are motivated by working for a company that shares those values.

Why Oncopeptides?
At Oncopeptides, you will join a dedicated, science-driven organization where every role contributes to advancing patient safety and improving lives. Oncopeptides encourage courage, trust, and collaboration and celebrate curiosity and innovation. Here, science meets purpose, and passion drives progress. This role offers exposure across global pharmacovigilance, the opportunity to work with new systems and regulatory interfaces and room for professional growth and advancement

The Recruitment Process - Your Application
PharmaRelations is managing this recruitment on behalf of Oncopeptides. If you believe your background and expertise align with the requirements, we encourage you to submit your application through the “Apply” button. We will review all applications with great care in our search for the right candidate. A kind reminder is that the application documents should not be sent via email. For questions regarding the position, you are welcome to contact Kristina Edholm ([email protected]).