Pharmacovigilance Medical Writer II
Work Model: Remote
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Part of Ergomed PLC)
About PrimeVigilance
PrimeVigilance is a specialised mid-size pharmacovigilance service provider founded in 2008. With continuous global growth, the company has teams across Europe, North America, and Asia delivering expert services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
The organisation partners with pharmaceutical and biotechnology companies of all sizes across all therapeutic areas, including medical devices. PrimeVigilance emphasises:
High-quality client service
Long-term partnerships
Employee training and career growth
Work–life balance and mental well-being
Role Overview
The Medical Writer II – Pharmacovigilance will be responsible for advanced medical writing tasks, primarily focused on aggregate safety reports. The role requires prior experience in aggregate report writing and the ability to mentor junior writers.
Key Responsibilities
Aggregate Report Writing
Preparation, review, and quality control of:
PSURs / PBRERs
PADERs
ACOs
DSURs
RMPs
Quality & Compliance
Review of outputs created by operations teams
Completing required quality documentation
Identifying opportunities for process improvement
Supporting updates to SOPs, Operational Guidelines, and templates
Providing training related to aggregate report writing
Project & Client Interaction
Supporting Project Managers in scheduling and planning aggregate reports
Participating in client kick-off meetings
Representing the team during audits and inspections
Leadership & Training
Training and mentoring Associate Medical Writers
Offering guidance on writing standards and regulatory expectations
Qualifications
Education
MD, Pharmacy, or Life Science degree
Master’s or PhD preferred
Experience
Strong prior experience in Pharmacovigilance:
Aggregate safety report writing (essential)
Case processing, signal detection, or risk management (preferred)
CRO experience is desirable
Skills
Excellent attention to detail
Ability to prioritise multiple tasks
Capability to train and guide junior writers
Strong teamwork and communication skills
Fluency in English (additional languages beneficial)
Why Join PrimeVigilance?
Comprehensive internal training and career development
Strong focus on personal and professional growth
Friendly, collaborative working environment
Opportunity to work with global colleagues (English as main company language)
Inclusive culture promoting diversity, equity, and belonging
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 :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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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 :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Japan | Saitama |Tokyo :
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