Job Title: PV Officer (Senior Level Position)
Location: Zagreb, Croatia
Job Type: Full-time
Department: ICSR Management
About the Company:
PrimeVigilance, part of Ergomed Group, is a specialized pharmacovigilance service provider established in 2008. The company has consistently experienced global organic growth, with staff based across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming a global leader in its field. The company invests in employee well-being, offering excellent training and development platforms, with a focus on work-life balance to ensure high-quality client service.
Job Responsibilities:
Case Processing:
Manage Individual Case Safety Reports (ICSRs) from all sources (post-marketing, clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements
Perform and support pharmacovigilance activities on behalf of PrimeVigilance, covering all steps of a workflow cycle, except Medical Review
Independent Management:
Handle SAE/SUSAR submissions, unblinding, and clinical trial reconciliations
Prepare database outputs for periodic reporting (e.g., PBRER, DSUR, PADER)
Mentoring & Training:
Mentor and train new and junior employees within the department, optimize procedures, and contribute to their development
Required Qualifications:
Education:
Life science or biomedical background (e.g., chemistry, biology, biotechnology, veterinary science) with a healthcare-related degree
Experience:
Demonstrated experience in pharmacovigilance case processing
Skills:
Strong time and issue management, delegation, organization, and multitasking skills
Excellent attention to detail
Strong interpersonal and communication skills
Advanced English proficiency (C1 or above) in both verbal and written communication
Additional Information:
PrimeVigilance prioritizes diversity, equity, and inclusion, fostering an equal opportunities workplace where people from all cultural backgrounds, genders, and ages can contribute and grow.
The company adopts a human-first approach, believing its people are the greatest strength driving the continued success in improving lives globally.
PrimeVigilance offers internal training, career development, and a friendly, supportive working environment with colleagues from around the world.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Boulder | Denver | Westminster |Connecticut :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Mexico |northeastern :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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 :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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