Global Product Safety Science Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

Global Product Safety Science Lead overseeing safety management and collaboration with cross-functional teams in a biopharmaceutical company. Responsible for signal detection, benefit-risk evaluation, and regulatory compliance.

Posted 6/30/2026full-timeRemote • Basel • 🇨🇭 SwitzerlandSeniorWebsite

Tech Stack

Tools & technologies

SQL

About the role

Key responsibilities & impact

Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).
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 (e.g. PSURs, DSURs, RMPs, regulatory responses).
Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions.
Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of 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.
Chair product‑level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs.

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
Experience presenting medical safety information at Health Authority meetings
Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Sobi - Swedish Orphan Biovitrum AB (publ) Website LinkedIn All Job Openings 1001 - 5000 employees Founded 1991 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Biotechnology
Pharmaceuticals
Healthcare Insurance Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions. Global Product Safety Science Lead 🔥 59 minutes ago 🇨🇭 Switzerland – Remote ⏰ Full Time 🟠 Senior ✅ Product Manager Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).
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 (e.g. PSURs, DSURs, RMPs, regulatory responses).
Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions.
Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of 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.
Chair product‑level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs. 🎯 Requirements
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
Experience presenting medical safety information at Health Authority meetings
Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements Apply Now 📊 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 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

Data AnalysisMedical Safety Data SynthesisAggregate Report WritingSafety Risk ManagementRegulatory Response Preparation

Soft Skills

Strong CommunicationStakeholder Collaboration

Certifications

MDPharmDPhDMaster’s in Life SciencesMaster’s in Public Health