Pharmacovigilance Specialist – Homebased, Germany | ICON Strategic Solutions
Employer: ICON Strategic Solutions
Location: Germany (Homeworking)
Salary: Competitive
Start Date: 23 November 2025
Closing Date: 23 December 2025
Experience Required: Minimum 3 years in pharmaceutical/R&D or pharmacovigilance roles
About ICON Strategic Solutions
ICON plc is a global leader in healthcare intelligence and clinical research services. The organization is committed to advancing the future of clinical development through innovation, scientific excellence, and a collaborative, inclusive culture. As a Pharmacovigilance Specialist, you will support global safety activities, contribute to high-quality safety assessments, and play a key role in delivering compliant safety documentation for regulatory authorities.
Position Overview: Pharmacovigilance Specialist
This role is responsible for executing end-to-end pharmacovigilance activities, with a focus on signal detection, risk management planning, periodic safety reporting, and safety input for clinical trials and regulatory submissions. You will collaborate with cross-functional global teams to ensure compliant, data-driven, and scientifically robust safety outputs.
Key Responsibilities
1. Signal Detection and Safety Surveillance
Conduct ongoing safety monitoring using tools such as Spotfire, Empirica Signals, and other analytical platforms.
Review clinical and safety database outputs, evaluate aggregate safety data, and coordinate follow-up for missing information.
Review scientific (non-ICSR) literature to support ongoing safety surveillance and signal identification.
Analyze potential safety signals, prepare signal evaluation reports, and contribute to internal/external safety review meetings.
Support preparation of Emerging Safety Issue (ESI) Reports and communication to regulatory stakeholders.
2. Risk Management Plans (RMPs) & Periodic Safety Reports
Retrieve and summarize safety data to support RMP updates and adaptations.
Contribute as a document author for RMP sections and periodic safety reports.
Support safety profile evaluation including identification of important risks or safety concerns.
Prepare responses to Health Authority (HA) queries related to RMPs or periodic safety submissions.
3. Regulatory Submissions & Safety Variations
Provide safety input into CTD safety documents and regulatory dossiers.
Contribute to documents such as ISS/SCS IAP, HA briefing materials, Modules 2.7.4 / 2.5, and product information.
Provide safety content for Clinical Overview Addenda.
Draft responses to HA questions related to submissions or safety variations.
4. Clinical Trial Safety Support
Provide safety insights for IMPD, Investigator’s Brochure (IB), and Informed Consent Forms (ICF).
Support development of clinical trial protocols and search strategies for integrated analysis plans.
Provide input for Data Monitoring Committee (DMC) materials including charters and meeting summaries.
Draft HA responses related to clinical trial safety applications.
5. Additional Responsibilities
Participate in audits and inspections within scope of responsibility.
Contribute to design and implementation of post-authorization safety studies (PASS).
Support Due Diligence activities through preliminary safety reviews.
Develop and maintain MedDRA CMQs for signal analysis and aggregate data review.
Create product-specific training materials for internal and external stakeholders.
Provide expert input for process standardization, operational improvements, and PV best practices.
Required Qualifications
MD, PhD, or advanced scientific degree in biomedical or health-related field.
Fluent in written and spoken English.
Professional Experience Required
Minimum 3 years of pharmaceutical industry experience in R&D, pharmacovigilance, clinical development, medical affairs, regulatory affairs, or related roles.
Prior pharmacovigilance experience preferred.
Experience in scientific literature review (Non-ICSR literature) is essential.
Demonstrated experience in signal detection and safety data analysis.
Experience working in cross-functional, global teams across multiple regions.
What ICON Offers
ICON provides competitive reward packages designed to support well-being, work–life balance, and long-term career development. Benefits may include:
Annual leave entitlements
Health insurance options for employees and families
Retirement planning programs
Global Employee Assistance Programme (LifeWorks)
Life assurance
Country-specific benefits such as childcare vouchers, gym discounts, travel subsidies, and wellness programs
Detailed country-specific benefits are available on ICON’s careers site.
Inclusion and Accessibility
ICON is committed to fostering a workplace grounded in inclusion, belonging, and equal opportunity. All qualified applicants will receive consideration without regard to race, gender, identity, nationality, disability, or veteran status. Reasonable accommodations for disabilities are available upon request.
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Witney |Ontario :
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Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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