Global Product Safety Science Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

Lead safety science for product lifecycle within Sobi, focusing on pharmacovigilance and product safety. Collaborating with global teams, driving safety strategies and risk management for rare disease treatments.

Posted 6/30/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Perform and lead safety surveillance and benefit–risk activities for assigned products
Set the strategy for safety signal detection methodology
Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented
Lead and perform assessments for preparation, review and approval of key safety deliverables
Translate safety data insights into actionable recommendations
Lead clinical safety science interactions with partner companies
Act as the Safety Science representative in the Medical Development Team (MDT)
Provide clinical safety input into study design, conduct, analysis and interpretation
Chair product-level Benefit Risk Teams (BRTs)
Represent the BRT at Benefit Risk Council (BRC)
Mentor colleagues and support capability development within the product safety team

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
Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements

Benefits

Comp & perks

N/A 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Safety SurveillanceBenefit-Risk AssessmentData AnalysisMedical InterpretationPharmacovigilance Processes

Soft Skills

Strong CommunicationStakeholder CollaborationMentoring

Certifications

MDPharmDPhDMaster’s in Life SciencesMaster’s in Public Health