Global Product Safety Science Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

. Perform and lead signal detection, evaluation, validation and escalation activities for assigned products .

Posted 10/2/2026full-timeRemote • SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in pharmacovigilance and safety science, with a strong focus on signal detection, benefit-risk evaluation, and regulatory compliance. Proficient in data analysis and visualization tools to support safety assessments and decision-making.

Highest-signal resume keywords

Pharmacovigilance ExpertiseSignal Detection MethodologyBenefit-Risk EvaluationRegulatory ComplianceCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Signal DetectionBenefit-Risk EvaluationPharmacovigilance ProcessesData AnalysisMedical Safety StrategyAggregate Report WritingSafety Risk ManagementRegulatory InteractionsSafety Data InsightsClinical Safety Input

Soft Skills

Strong Communication SkillsStakeholder CollaborationAnalytical SkillsEffective LeadershipRelationship Building

Tools & Technologies

ExcelSQLPower BISpotfireAI-Enabled Tools

Certifications & Qualifications

MDPharmDPhDMaster’s in Life Sciences/Public Health

Industry Keywords

Global PV RegulationsGVPICH E2ESafety SciencePharmaceutical EnvironmentRegulatory EnvironmentHealth Hazard AssessmentMedical Development TeamSafety Signal ProcessMarket Approvals

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

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
Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented
Lead and perform assessments for 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 and ensure sharing of safety information per the SDEA and collaborative functioning of the JSMT
Provide safety scientific input to the ISS Evaluation Committee as required
Work cross-functionally on product quality escalations and, when required, lead preparation of medical impact Health Hazard Assessment statements
Act as Safety Science representative in the Medical Development Team and integrate safety 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 clinical safety strategy, Target Product Profile, and maintenance of the RSI, including IB and CDS governance
Chair product-level Benefit Risk Teams and represent the BRT at Benefit Risk Council
Serve as primary decision-maker for product-level safety issues, including signal validation and escalation
Lead interactions with external partners and service providers related to product safety deliverables
Support product-level regulatory interactions, inspections and audits
Mentor colleagues and support capability development within the product safety team
Use and develop safety systems, data visualization tools and AI-enabled analyses to support signal detection, safety assessments and decision-making
Identify opportunities for process, data and system improvements within Safety Science
Work independently with accountability for assigned products, escalating complex or cross-product issues as appropriate

Requirements

What you’ll need

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 PV regulations (e.g., GVP, ICH E2E), pharmacovigilance processes and practices
Proficiency to analyse, synthesize medical & scientific safety data and contribute to scientific interpretation
Strong communication & stakeholder collaboration skills
Proficiency in Excel, database querying (e.g., SQL), and basic data visualization (e.g., Power BI, Spotfire), AI-related tools
Experience working with development programs and with products with market approvals
Experience leading cross functional global product safety management teams, successfully delivering medical safety strategy, with experience across safety signal process, aggregate report writing, safety risk communication and safety risk management
Desired: Experience working with partner companies to successfully develop and market products across global markets
Desired: Experience presenting medical safety information at Health Authority meetings
Desired: Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements
High quality written and spoken English
Strong analytical skills
Effective communicator (oral, writing, presentations) at all levels of the business
Ability to work effectively to fulfil ambitious goals
Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive
Demonstrated ability to lead safety activities and scientific discussions
Strong team-leadership capabilities
Demonstrated relationship builder both internally and externally; a strong collaborator within PV function, leadership and the wider organisation

Benefits

Comp & perks

Employees can work remotely