Job Title:
Pharmacovigilance Officer, Team Leader (Line Management Position)
Location:
Zagreb, Croatia
Employment Type:
Full-time
Department:
ICSR Management
Company Overview:
PrimeVigilance, part of the Ergomed Group, is a specialised mid-size pharmacovigilance service provider established in 2008. The company has staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and becoming a global leader in its field. The company invests in staff training and development and emphasizes work-life balance to foster high-quality client service.
Job Overview:
The Pharmacovigilance Officer, Team Leader, is responsible for overseeing ICSR management activities in line with regulatory requirements and client expectations. The role includes line management, mentoring, and supporting PV processes for both PrimeVigilance and clients.
Key Responsibilities:
ICSR & Safety Management:
Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, company procedures, and client-specific requirements.
Perform ICSR follow-up and SAE/SUSAR management, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.
Conduct clinical and partner reconciliation.
Ensure personal data protection and handle Product Quality Complaints in coordination with Quality Assurance.
Interact with Medical Information for safety-related inquiries.
Perform MedDRA and WHO coding.
Generate database outputs and reports, including monthly client reporting.
Team Leadership & Mentoring:
Mentor and train new and junior staff within the department.
Manage workflow and resources efficiently.
Support and contribute as an ICSR Subject Matter Expert (SME).
PV Support & Compliance:
Support PV processes related to ICSR management for PrimeVigilance and clients.
Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated countries/languages, as agreed with line manager.
Support the RA & PV Network Department as required.
Qualifications:
Life science graduate, pharmacy, nursing, or other healthcare-related qualification, or equivalent pharmacovigilance experience.
Extensive ICSR experience, including mentoring and line management.
Excellent written and verbal communication skills.
Strong organizational skills, attention to detail, multitasking, delegation, and time management.
Team-working and technical proficiency.
Fluent in English (spoken and written).
Why PrimeVigilance:
Opportunities for internal training and career development.
Strong emphasis on personal and professional growth.
Friendly, supportive, international working environment.
Collaboration with colleagues worldwide, with English as the company language.
Core Values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Bhubaneswar | Rourkela |PAN-India :
Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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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 :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Charleston |Tennessee :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
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 :
Witney |South Yorkshire :
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 :
Richmond Hill | Australia | Renfrew | North York | Uxbridge | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
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Turku |France :
Lyon | Paris |Attica :
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Greece |East Java :
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Italy |Lombardy :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
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Warsaw |Remote :
Lenexa | Melbourne | Hammond | Switzerland | Riga | Lousiana | Remote - Middle East | Belgium | Victoria | Bountiful | Remote - South America (Latin Americal) | Ireland | Thailand | Green Way | Remote - Africa | Castlebar | Remote - Europe | Xzagreb | McFarland | Leinster | Slovakia | Bishop | Manipal | Remote, USA | Blue Bell | Remote | Nairobi | Medan | Zaragoza | Hungary | Minnesota | French | Texas | Springville | Faridabad | Tulsa |Bucharest :
Bucharest |Makkah :
Riyadh | King Abdullah Economic City | Najran | Khulais | Rabigh | Jeddah |Nišava District :
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Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |