S

Sobi

Develops therapies for rare diseases

Global Product Safety Science Lead

Full-TimeUpdated on 10/15/2026
No salary listed
Mid
Master's, PharmD, PhD
Basel, Switzerland
Remote
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A required MD, PharmD, PhD, or Master’s in Life Sciences/Public Health.
  • Solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory environment.
  • Strong knowledge of global pharmacovigilance regulations, including GVP and ICH E2E, and pharmacovigilance processes and practices.
  • Proficiency in analyzing and synthesizing medical and scientific safety data and contributing to scientific interpretation.
  • Strong communication and stakeholder collaboration skills.
  • Proficiency in Excel, database querying such as SQL, basic data visualization such as Power BI or Spotfire, and AI-related tools.
  • Experience working with development programs and products with market approvals.
  • Experience leading cross-functional global product safety management teams and successfully delivering medical safety strategy, including safety signal processes, aggregate report writing, safety risk communication, and safety risk management.
  • High-quality written and spoken English.
  • Strong analytical skills.
  • Effective oral, written, and presentation communication at all levels of the business.
  • Ability to work effectively to fulfill ambitious goals.
  • Sound and balanced judgment; ability to assess and handle risks; self-confidence, proactivity, and decisiveness.
  • Demonstrated ability to lead safety activities and scientific discussions.
  • Strong team-leadership capabilities and demonstrated relationship-building internally and externally, including collaboration within the pharmacovigilance function, leadership, and the wider organization.
Responsibilities
  • Perform and lead signal detection, evaluation, validation, and escalation activities for assigned products.
  • Set the strategy for safety signal detection methodology, signal tracking, and oversight of safety signals for assigned products.
  • Drive, perform, and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented.
  • Lead and perform assessments for the preparation, review, and approval of key safety deliverables, including PSURs, DSURs, RMPs, and regulatory responses.
  • Translate safety data insights into actionable recommendations for product-level benefit-risk discussions and regulatory interactions.
  • Lead clinical safety science interactions with partner companies for assigned products, when applicable, ensuring safety information is shared per the SDEA and the JSMT is established and functions collaboratively.
  • Provide safety scientific input to the ISS Evaluation Committee as required.
  • For product quality escalations, work cross-functionally to understand patient impacts and, if required, lead preparation of a medical impact Health Hazard Assessment statement.
  • Act as the Safety Science representative in the Medical Development Team and ensure safety is integrated into product development and lifecycle decisions.
  • Provide clinical safety input into study design, conduct, analysis, and interpretation, including study-level Safety Lead responsibilities where applicable.
  • Provide medical and pharmacovigilance expertise for the product clinical development program’s clinical safety strategy, Target Product Profile development, and development and maintenance of the RSI, including IB and CDS.
  • Chair product-level Benefit Risk Teams and ensure effective operation according to SOPs.
  • Represent the Benefit Risk Team at the Benefit Risk Council.
  • Serve as the primary decision-maker for product-level safety issues, including signal validation and escalation.
  • Lead interactions with external partners and service providers related to assigned product safety deliverables.
  • Support product-level regulatory interactions, inspections, and audits.
  • Mentor colleagues and support capability development within the product safety team.
  • Use and continuously develop proficiency in safety systems, data visualization tools, and AI-enabled analyses, including Veeva Vault and analytics dashboards, to support signal detection, safety assessments, and decision-making for assigned products.
  • Identify opportunities for process, data, and system improvements within Safety Science.
Desired Qualifications
  • Experience working with partner companies to successfully develop and market products across global markets.
  • Experience presenting medical safety information at Health Authority meetings.
  • Demonstrated expertise in understanding, interpreting, and applying country- and regional-level pharmacovigilance requirements.

About the company

S

Sobi

View
Website

Sobi specializes in developing and delivering therapies for rare diseases. It focuses on hematology, immunology, and specialty care, bringing medicines to patients who have limited treatment options. Their products are designed to treat rare conditions and are typically administered by prescription under medical supervision; the company collaborates with partners to advance research, develop, and commercialize these therapies. Sobi differentiates itself through its strong biotechnological foundation from its Biovitrum heritage and a track record of strategic collaborations with major pharmaceutical players like Sanofi and Apellis, which expand its research capabilities and reach. The company’s goal is to improve the lives of patients with rare diseases worldwide by creating and delivering effective treatments that address unmet medical needs.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Solna kommun, Sweden

Founded

1988

Get referred to Sobi

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • EMA validated Tryngolza sHTG filing in March 2026, de-risking the European expansion path.
  • Aspaveli’s EU enFuse launch broadened home use, and Q1 2026 revenue rose 24%.
  • Arthrosi’s 2026 Phase 3 readouts can unlock a large gout market and justify premium valuation.

What critics are saying

  • Guido Oelkers leaves by January 2027, risking launch disruption during a pivotal year.
  • Tryngolza’s sHTG EU decision waits until 2027, delaying a major revenue expansion.
  • High debt and launch spending pressure margins if Aspaveli, Tryngolza, or pozdeutinurad disappoint.

What makes Sobi unique

  • Sobi owns rare-disease franchises across hematology, immunology, nephrology, and gout globally.
  • Tryngolza, Aspaveli, and Altuvoct create a multi-launch portfolio, not one-asset dependence.
  • Arthrosi adds pozdeutinurad, giving Sobi a late-stage gout platform and commercial rights.

Help us improve and share your feedback! Did you find this helpful?

Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) Company Match
  • Tuition Reimbursement
  • Wellness Program

Growth & Insights and Company News

Headcount

6 month growth

10%

1 year growth

10%

2 year growth

10%
Associated Press
Oct 1st, 2026
NICE recommends Tryngolza for ultra-rare lipid disorder treatment in England and Wales

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Tryngolza (olezarsen) for treating genetically confirmed familial chylomicronaemia syndrome (FCS) in adults in England and Wales. The treatment is approved only when diet and conventional triglyceride-lowering treatments prove inadequate. FCS is an ultra-rare inherited lipid disorder characterised by severe hypertriglyceridaemia and increased risk of acute pancreatitis. Around 114 people in the UK are diagnosed with FCS, though the condition is thought to be under-diagnosed. The recommendation follows positive Phase 3 Balance study results, where Tryngolza 80 mg demonstrated statistically significant reductions in fasting triglyceride levels at six months, sustained through 12 months. The treatment also showed clinically meaningful reductions in acute pancreatitis events. Sobi UK holds exclusive commercialisation rights for Tryngolza outside the US, except Canada and China.

Nu Pagamentos S.A. (Nubank)
Aug 7th, 2026
Swedish pharma Sobi acquires full control of Latin American oncology specialist Pint Pharma

Swedish biopharmaceutical company Sobi (Swedish Orphan Biovitrum) is acquiring full ownership of Pint Pharma, a firm specialising in bringing complex treatments, including cancer therapies, to Latin American markets. The transaction builds on Sobi's initial investment last year, when it paid $105 million for most of Pint's economic rights. The deal, submitted to Brazil's competition authority Cade, involves purchasing all remaining shares of Pharma Investments, Pint's parent company. The transaction value remains undisclosed. The acquisition gives Sobi control of a platform operating across seven Latin American markets, including Brazil, Mexico, Argentina, and Colombia. Pint handles regulatory approval, market access, and distribution of specialised medicines for rare diseases, haematology, and oncology. Sobi reported revenue of 28.2 billion Swedish kronor (approximately $2.9 billion) in 2025. The companies have maintained a commercial partnership since 2021.

Yahoo Finance
Aug 3rd, 2026
Swedish biopharma Sobi CEO Guido Oelkers to step down by January 2027

Swedish biopharma firm Sobi announced that chief executive Guido Oelkers will step down to take up another position outside the company. Oelkers will continue in his role until the end of January 2027 at the latest. "Leading Sobi has been a privilege, and I am proud of what we have accomplished together as a team," Oelkers said. He highlighted advancing the pipeline, expanding global footprint, and growing Sobi into a leader in rare diseases. The company will immediately begin searching for a new chief executive. Sobi's operations, strategy, and financial targets remain unchanged, the firm said.

PR Newswire
Jul 15th, 2026
Sobi repurchases shares at $0.05 to secure employee incentive programme commitments

Swedish Orphan Biovitrum (Sobi) is repurchasing shares to support its employee incentive programme. The Board of Directors exercised authorisation granted at the May 2026 Annual General Meeting to repurchase class C shares at approximately SEK 0.55 per share, representing 100% of their quotient value. The repurchase involves 223,677 shares and will occur between 16 July and 6 November 2026. Svenska Handelsbanken will handle the transaction. After converting the repurchased class C shares to common shares, Sobi will hold 10,290,974 own shares. The move secures commitments under the All Employee Programme, a long-term incentive scheme for permanent staff. Sobi, a biopharma company focused on rare diseases, employs approximately 2,000 people globally and reported revenue of SEK 28 billion in 2025.

Associated Press
May 22nd, 2026
Enable Injections' enFuse on-body delivery system receives CE certification for Aspaveli in EU

Enable Injections has received CE Certification for its enFuse On-Body Delivery System for use with Aspaveli (pegcetacoplan), which will be distributed by Swedish Orphan Biovitrum across the European Union as ASPAVELI enFuse. The certification allows caregivers and patients aged 12 and older to use the wearable device for subcutaneous drug administration. The enFuse system delivers medication through a discreet, hands-free device using a small, hidden needle, designed to improve patient self-administration. Aspaveli is approved for treating paroxysmal nocturnal haemoglobinuria, C3G and primary IC-MPGN in patients 12 years and older. This follows recent regulatory clearances in Saudi Arabia, Brazil, South Korea and Canada, part of Enable's strategic partnership with Sobi announced in September 2024.