Medical Writer I – Pharmacovigilance
Location: Zagreb, Croatia
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Part of Ergomed Group)
About PrimeVigilance
PrimeVigilance is a specialised mid-size pharmacovigilance service provider founded in 2008. The company has experienced continuous global growth, with teams across Europe, North America, and Asia delivering high-quality services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
The organisation supports pharmaceutical and biotechnology clients of all sizes and across all therapeutic areas, including medical devices. PrimeVigilance is committed to:
Employee development and training
Well-being and mental health
Work–life balance
Long-lasting client partnerships
Role Overview
The Medical Writer I – Pharmacovigilance will prepare, review, and ensure the quality of aggregate safety reports and related documentation in compliance with regulatory guidelines and company standards.
Key Responsibilities
Aggregate Report Writing
Preparation, quality checking, and review of:
PSURs / PBRERs
PADERs
ACOs
DSURs
RMPs
Quality & Compliance
Review of written output from operations teams
Completing required quality documentation for aggregate reports
Identifying process improvements with the Quality, Compliance & Training Manager
Supporting updates to SOPs, Operational Guidelines, and templates
Delivering training related to aggregate report processes
Project & Client Interaction
Supporting Project Managers in scheduling aggregate reports
Attending kick-off meetings with new clients
Participating in audits and inspections as required
Qualifications
Education
MD, Pharmacy, or Life Science degree
Master’s or PhD preferred
Experience
Knowledge/experience in Pharmacovigilance (case processing, signal detection, risk management)
CRO experience is desirable
Skills
Strong attention to detail
Ability to prioritise and manage multiple tasks
Excellent communication skills
Strong teamwork abilities
Fluency in English (additional languages advantageous)
Why Join PrimeVigilance?
Inclusive and diverse work environment
Emphasis on employee well-being and development
Internal training and career growth opportunities
Supportive and collaborative global team
Opportunity to work with international colleagues (English as the main company language)
Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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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 :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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