Job Title: Assistant II, Patient Safety Solutions (PSS)
Location: Sofia, Bulgaria (with occasional remote work)
Category: Clinical
Job ID: 254699
Contribute to clinical safety operations by supporting the collection, processing, and reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials and marketed products. Ensure data quality, regulatory compliance, and patient safety while collaborating across cross-functional teams.
Adverse Event Processing
Collect, process, and report AEs and SAEs from various sources.
Enter safety data into tracking systems, ensuring accuracy and completeness.
Draft patient narratives and code adverse events using MedDRA.
Assist with safety database reconciliation and quality checks.
Prepare and submit safety reports to clients, regulatory authorities, ethics committees, and investigators within agreed timelines.
Documentation & Compliance
Maintain project documentation, safety files, and study archives.
Support adherence to global safety and regulatory requirements.
Assist in maintaining Standard Operating Procedures (SOPs), Work Instructions (WIs), and other regulatory documents.
Collaboration & Training
Collaborate with colleagues across safety, regulatory, and clinical functions.
Support training and mentorship of junior staff as needed.
Contribute to fostering a culture of compliance, quality, and patient safety.
Education & Experience
Degree in Life Sciences (Biology, Pharmacy, Nursing, Medical Sciences, or related field) or equivalent experience.
1–2 years of experience in safety case processing, pharmacovigilance, or related clinical research.
Skills & Competencies
Familiarity with safety databases, AE/SAE reporting, and regulatory submissions.
Strong attention to detail with the ability to manage multiple tasks effectively.
Proficiency in MS Office; ability to quickly learn new systems.
Fluent in English (written and spoken); local language proficiency may be required.
Office-based in Sofia, with flexibility for remote work.
Compliance with Health and Safety regulations and company policies.
Opportunity to improve patient safety in a global healthcare environment.
Supportive, collaborative workplace culture with growth opportunities.
Access to training, mentoring, and career development programs.
Diverse and inclusive environment valuing multiple perspectives.
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Germany | GErmany |Hesse :
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Finland |Hungary :
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Norway | NOrway |Romania :
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Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
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Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Richmond Hill | Mississauga | Uxbridge | Australia | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Netanya | Yavne | Be'Er Sheva | Tel Aviv | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Manila |Mazovia :
Warsaw |Remote :
Bountiful | Blue Bell | Switzerland | Belgium | Hungary | Xzagreb | Remote - South America (Latin Americal) | Remote - Middle East | Remote - Africa | Melbourne | Manipal | Tulsa | Zaragoza | Remote | Victoria | Thailand | Castlebar | Green Way | Riga | Texas | Ireland | Medan | Hammond | Remote, USA | Lousiana | Bishop | Remote - Europe | McFarland | Nairobi | Faridabad | Leinster | Minnesota | Springville | French | Slovakia | Lenexa |Bucharest :
Bucharest |Makkah :
King Abdullah Economic City | Najran | Riyadh | Rabigh | Jeddah | Khulais |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Sao paulo | Brazil |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Ho Chi Minh City |