Global Product Safety Science Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

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

Posted 10/2/2026full-timeRemote • United KingdomSeniorWebsite

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, leading cross-functional teams, and effective communication with stakeholders.

Highest-signal resume keywords

Pharmacovigilance ExpertiseGlobal PV Regulations KnowledgeData Analysis and SynthesisCross-Functional Team LeadershipBenefit-Risk Evaluation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Signal DetectionBenefit-Risk EvaluationAggregate Report WritingSafety Risk ManagementMedical Safety Strategy

Soft Skills

Strong Communication SkillsStakeholder CollaborationAnalytical SkillsTeam LeadershipRelationship Building

Tools & Technologies

ExcelSQLPower BISpotfireAI-Enabled Tools

Certifications & Qualifications

MDPharmDPhDMaster’s in Life SciencesMaster’s in Public Health

Industry Keywords

PharmaceuticalRegulatory EnvironmentSafety ScienceGVPICH E2E

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Perform and lead signal detection, evaluation, validation and escalation for assigned products
Set strategies for safety signal detection methodology, signal tracking and oversight
Drive and document benefit-risk evaluations and implement risk-management strategies
Lead assessments and preparation, review and approval of PSURs, DSURs, RMPs and regulatory responses
Translate safety data insights into recommendations for product-level benefit-risk discussions and regulatory interactions
Lead clinical safety science interactions with partner companies and ensure safety-information sharing
Provide safety scientific input to the ISS Evaluation Committee
Assess product-quality escalation impacts on patients and lead Health Hazard Assessment statements when required
Represent Safety Science in the Medical Development Team and integrate safety into development and lifecycle decisions
Provide clinical safety input into study design, conduct, analysis and interpretation
Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile, RSI, IB and CDS governance
Chair product-level Benefit Risk Teams and represent them at the Benefit Risk Council
Serve as primary decision-maker for product-level safety issues
Lead interactions with external partners and service providers
Support product-level regulatory interactions, inspections and audits
Mentor colleagues and support capability development
Use and develop safety systems, data visualization tools and AI-enabled analyses for signal detection, safety assessments and decision-making
Identify process, data and system improvement opportunities within Safety Science
Work independently with accountability for assigned products and escalate complex issues appropriately

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, including GVP and ICH E2E
Proficiency to analyse and synthesize medical and scientific safety data and contribute to scientific interpretation
Strong communication and stakeholder collaboration skills
Proficiency in Excel, database querying such as SQL, basic data visualization such as Power BI and 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 delivering medical safety strategy
Experience across 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 skills
Ability to work effectively to fulfil 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
Demonstrated relationship-building and collaboration skills internally and externally

Benefits

Comp & perks

Employees can work remotely