Global Product Safety Science Lead

Product ManagerProduct ManagerFull TimeRemoteSeniorTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

3 days ago

Salary

0

Seniority

Senior

Postgraduate DegreeEnglishSQL

Job Description

Global Product Safety Science Lead

Sobi - Swedish Orphan Biovitrum AB (publ)

• 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

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

Benefits

  • N/A

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