Pharmacovigilance Specialist – Germany (Remote)
Employer: ICON Strategic Solutions
Location: Germany | Homeworking
Job Category: Pharmacovigilance / Drug Safety
Salary: Competitive
Start Date: 23 November 2025
Closing Date: 23 December 2025
About the Company
ICON Strategic Solutions, part of ICON plc, is a global leader in healthcare intelligence and clinical research. The organization is committed to driving innovation, advancing scientific excellence, and transforming clinical development worldwide. As an inclusive and diverse workplace, ICON empowers professionals to build meaningful careers while contributing to high-impact global projects.
Position Overview
ICON Strategic Solutions is seeking a skilled Pharmacovigilance Specialist to support global safety monitoring, signal detection, regulatory submissions, and safety reporting activities. This remote role offers the opportunity to contribute to end-to-end drug safety operations across clinical trials and post-marketing settings while collaborating with cross-functional, international teams.
This position is ideal for professionals who have experience in PV, clinical development, medical affairs, or regulatory affairs and are looking to advance their expertise within a leading global organization.
Key Responsibilities
Signal Detection and Safety Monitoring
Perform safety monitoring using dedicated tools such as Spotfire and Empirica Signals.
Review and assess clinical and safety database outputs.
Analyze aggregate safety data from clinical trials and post-marketing sources.
Review scientific literature for safety surveillance and signal detection.
Author signal evaluation reports and contribute to safety review meetings.
Support development and communication of Emerging Safety Issue Reports.
Risk Management Plans (RMPs) & Periodic Safety Reports
Summarize and retrieve safety data for regulatory documentation.
Provide scientific input into RMPs and periodic safety reports.
Support country-specific adaptations of RMPs.
Prepare responses to health authority questions.
Submissions and Safety Variations
Contribute to safety sections of CTDs, ISS/SCS, briefing documents, and product information.
Provide safety input into Clinical Overview Addendums.
Prepare responses to regulatory queries.
Clinical Trial Support
Provide safety-related content for IMPD, IB, ICF, protocols, and database setup.
Support Data Monitoring Committee materials, charter reviews, and meeting minutes.
Provide responses to health authority questions for clinical trial applications.
Additional Responsibilities
Participate in audits and inspections.
Support design and execution of post-authorization safety studies.
Conduct preliminary safety assessments for Due Diligence activities.
Maintain MedDRA CMQs for signal analysis.
Develop product-specific safety training for stakeholders.
Contribute to process improvements and standardization initiatives.
Education Requirements
MD, PhD, advanced science degree, or tertiary qualification in a biomedical or health-related field.
Fluent written and spoken English is mandatory.
Experience Required
Minimum 3 years of pharmaceutical industry experience in R&D functions such as PV, clinical development, medical affairs, or regulatory affairs.
Prior Pharmacovigilance experience preferred.
Experience working with global, cross-functional teams is an advantage.
Experience in scientific literature review of non-ICSR literature is required.
Signal detection experience is mandatory.
What ICON Offers
ICON provides a competitive compensation package and comprehensive benefits designed to support 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.
Flexible, country-specific optional benefits such as childcare vouchers, gym discounts, travel subsidies, and more.
Inclusion & Accessibility
ICON is committed to creating an inclusive, accessible, and discrimination-free workplace. Reasonable accommodations are available for candidates requiring support during the recruitment process or in performing the role.
How to Apply
If you meet the requirements and are interested in advancing your career in Pharmacovigilance, apply through ICON Strategic Solutions. Candidates who may not meet every requirement are still encouraged to apply, as ICON values diverse talent.
Gujarat :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Budapest |BULGARIA :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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