PrimeVigilance
Job title:
Medical Author – Pharmacovigilance – Japanese & English langauge
Firm
PrimeVigilance
Job description
Firm DescriptionWe’re PrimeVigilance (a part of Ergomed Gorup), a specialised mid-size pharmacovigilance service supplier initially established in 2008. We’re proud to have achieved world natural development 12 months after 12 months, with employees primarily based throughout Europe, North America and Asia all overlaying companies inside: Medical Data, Pharmacovigilance, Regulatory Affairs and High quality Assurance.PrimeVigilance gives top quality help to our small to massive pharmaceutical and biotechnology companions sustaining lengthy lasting relationships and turning into one of many world leaders in its fields. We cowl all remedy areas together with medical units.We love investing in our employees by offering a wonderful coaching and growth platform. We worth worker expertise, well-being and psychological well being and we acknowledge {that a} wholesome work life stability is a important issue for worker satisfaction and in flip nurtures an atmosphere from which a high-quality shopper service could be achieved.Job DescriptionWe’re in search of a pharmacovigilance medical author fluent in English and Japanese to hitch our group. The Medical Author shall be liable for medical writing together with:
- PSURs/PBRERs
- PADERs
- ACOs
- DSURs
- RMPs
- QC and evaluation of all written output from the operations group as required
- Supporting the undertaking managers to find out scheduling of the combination studies for which they’re accountable
- Together with the High quality, Compliance and Coaching Supervisor establish areas for enchancment and tackle through coaching, clarifying adjustments to SOPs/OGs/templates
- Full high quality documentation of mixture studies
- Attending kick off conferences with new purchasers as required
- Attending audits and inspections as required
- Offering mixture report coaching
{Qualifications}
- MD, pharmacy or Life Science diploma (Masters or PhD is fascinating)
- Means to handle a number of and diversified duties and prioritize workload with consideration to element
- Have to be a robust group participant
- Fluency in English and Japanese
Further DataWhy PrimeVigilanceWe prioritize variety, fairness, and inclusion by creating an equal alternatives office and a human-centric atmosphere the place individuals of all cultural backgrounds, genders and ages can contribute and develop.To succeed we should work along with a human first method. Why? as a result of our individuals are our biggest energy resulting in our continued success on enhancing the lives of these round us.We provide:
- Coaching and profession growth alternatives internally
- Sturdy emphasis on private {and professional} development
- Pleasant, supportive working atmosphere
- Alternative to work with colleagues primarily based everywhere in the world, with English as the corporate language
Our core values are key to how we function, and for those who really feel they resonate with you then PrimeVigilance might be an awesome firm to hitch!
- High quality
- Integrity & Belief
- Drive & Ardour
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
Come and be a part of us on this thrilling journey to make a optimistic influence in affected person’s lives. We sit up for welcoming your utility.
Anticipated wage
Location
Guildford, Surrey
Job date
Sat, 06 Apr 2024 22:37:10 GMT
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