Basel, Basel-City, Switzerland · On-site
Company Description Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and…
Skills: Pharmacovigilance, Safety Science, Signal Detection, Benefit-Risk Evaluation, GVP
Paderborn, North Rhine-Westphalia, Germany · On-site
Unternehmensbeschreibung Statistiken zeigen, dass Frauen und Angehörige unterrepräsentierter Gruppen sich häufig nur dann auf Stellen bewerben, wenn sie 100 % der Anforderungen erfüllen. Sobi ermutigt Sie, diese Statisti…
Skills: Key Account Management, Pharmaceutical Sales, Market Analysis, Stakeholder Management, Strategic Planning
Bremen, Bremen, Germany · On-site
Unternehmensbeschreibung Statistiken zeigen, dass Frauen und Angehörige unterrepräsentierter Gruppen sich häufig nur dann auf Stellen bewerben, wenn sie 100 % der Anforderungen erfüllen. Sobi ermutigt Sie, diese Statisti…
Skills: Key Account Management, Pharmaceutical Sales, Market Analysis, Stakeholder Management, Strategic Planning
Oldenburg, Lower Saxony, Germany · On-site
Unternehmensbeschreibung Statistiken zeigen, dass Frauen und Angehörige unterrepräsentierter Gruppen sich häufig nur dann auf Stellen bewerben, wenn sie 100 % der Anforderungen erfüllen. Sobi ermutigt Sie, diese Statisti…
Skills: Key Account Management, Pharmaceutical Sales, Market Analysis, Stakeholder Management, Strategic Planning
Morristown, New Jersey, United States · On-site
$140k–$165k/yr
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role exc…
Skills: Small Molecule Manufacturing, Process Validation, CMC Development, Product Transfer, Scale-up Activities
Philadelphia, Pennsylvania, United States · On-site
$140k–$165k/yr
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role exc…
Skills: Small Molecule Manufacturing, Process Validation, CMC Development, Product Transfer, Scale-up Activities
Waltham, Massachusetts, United States · On-site
$140k–$165k/yr
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role exc…
Skills: Small Molecule Manufacturing, Process Validation, CMC Development, Product Transfer, Scale-up Activities
Morrisville, North Carolina, United States · On-site
$140k–$165k/yr
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role exc…
Skills: Small Molecule Manufacturing, Process Validation, Life Cycle Management, CMC Development, Product Transfer
Raleigh, North Carolina, United States · On-site
$260k–$295k/yr
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role exc…
Skills: Medical Affairs Strategy, Immunology, KOL Engagement, Evidence Generation, Life Cycle Management
Stockholm, Sweden · On-site
Company Description Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and…
Skills: Pharmacovigilance, Safety Science, Signal Detection, Benefit-Risk Evaluation, GVP
Basel, Basel-City, Switzerland · On-site
Company Description Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and…
Skills: Pharmacovigilance Agreements, Regulatory Compliance, Negotiation, Patient Safety, Alliance Management
Cambridge, England, United Kingdom · On-site
Company Description Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and…
Skills: Pharmacovigilance Agreements, Regulatory Compliance, Negotiation, Patient Safety, Alliance Management
Bielefeld, North Rhine-Westphalia, Germany · On-site
Unternehmensbeschreibung Statistiken zeigen, dass Frauen und Angehörige unterrepräsentierter Gruppen sich häufig nur dann auf Stellen bewerben, wenn sie 100 % der Anforderungen erfüllen. Sobi ermutigt Sie, diese Statisti…
Skills: Key Account Management, Pharmaceutical Sales, Market Analysis, Stakeholder Management, Strategic Planning
Basel, Basel-City, Switzerland · Remote OK
Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates …
Skills: Analytical Chemistry, QC Laboratory Methods, Chromatography, Spectroscopy, ELISA
Stockholm, Sweden · Remote OK
Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates …
Skills: Analytical Chemistry, QC Laboratory Methods, Chromatography, Spectroscopy, ELISA
Waltham, Massachusetts, United States · On-site
$275k–$340k/yr
Company Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role exc…
Skills: Global Asset Strategy, Lifecycle Management, Cross-functional Leadership, Stakeholder Management, Regulatory Submissions
Bielefeld, North Rhine-Westphalia, Germany · On-site
Unternehmensbeschreibung Statistiken zeigen, dass Frauen und Angehörige unterrepräsentierter Gruppen sich häufig nur dann auf Stellen bewerben, wenn sie 100 % der Anforderungen erfüllen. Sobi ermutigt Sie, diese Statisti…
Skills: Key Account Management, Pharmaceutical Sales, Market Analysis, Stakeholder Management, Strategic Planning
Bielefeld, North Rhine-Westphalia, Germany · On-site
Unternehmensbeschreibung Statistiken zeigen, dass Frauen und Angehörige unterrepräsentierter Gruppen sich häufig nur dann auf Stellen bewerben, wenn sie 100 % der Anforderungen erfüllen. Sobi ermutigt Sie, diese Statisti…
Skills: Key Account Management, Sales Strategy, Market Analysis, Stakeholder Management, Customer Engagement
Munich, Bavaria, Germany · On-site
Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates …
Skills: International Launch Planning, Diagnostic Strategy, Stakeholder Management, Cross-functional Collaboration, Nephrology Care Pathways
Paris, Ile-de-France, France · On-site
Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates …
Skills: International Launch Planning, Diagnostic Strategy, Rare Disease Commercialization, Stakeholder Management, Cross-functional Leadership
Basel, Basel-City, Switzerland • On-site
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Lead safety surveillance and benefit-risk activities for assigned products across their lifecycle, ensuring integration of safety into development decisions. Drive the implementation of safety strategies and manage key regulatory deliverables such as PSURs, DSURs, and RMPs.
Requires an advanced degree (MD, PharmD, PhD, or Master's) in Life Sciences or Public Health with extensive experience in pharmacovigilance and safety science. Must possess strong analytical skills and proficiency in safety data tools and global regulatory requirements.
Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. You can find more information about Sobi at www.sobi.com.
The Global Product Safety Science Lead (GPSSL) is responsible for performing and leading safety surveillance and benefit–risk activities for one or more assigned products across the product lifecycle.
This role combines scientific leadership and hands‑on execution and represents the primary product‑level safety owner.
The GPSSL drives safety strategy implementation in collaboration with other colleagues within Safety Science, chairs benefit–risk discussions and ensures high‑quality safety deliverables within cross‑functional product teams, including active participation in the Medical Development Team (MDT), ensuring that safety considerations are fully integrated into development and lifecycle decisions, in compliance with GVP, GCP and global regulatory requirements.
The GPSSL works collaboratively with other members of the Sobi Global Pharmacovigilance team, and other internal functions across Sobi or externally to ensure proactive safety management, high‑quality regulatory safety deliverables and effective communication of clinical safety throughout the product lifecycle.
Level of autonomy: works independently with accountability for assigned products, escalating complex or cross‑product issues as appropriate.
Education/Learning Experience/Work Experience
Required:
Desired:
Skills/Knowledge/Languages
Required:
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. We are dedicated to capturing the scientific opportunities of our time. With our early roots in Sweden, we started as pioneers in haemophilia. Today we are an innovative leader within rare diseases with a global reach. Together we are bringing brilliant ideas to life. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
Offices: Norra Stationsgatan 93A, Stockholm, Stockholm County 11364, SE
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. We are dedicated to capturing the scientific opportunities of our time. With our early roots in Sweden, we started as pioneers in haemophilia. Today we are an innovative leader within rare diseases with a global reach. Together we are bringing brilliant ideas to life. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
Offices: Norra Stationsgatan 93A, Stockholm, Stockholm County 11364, SE
