Medical Writer (Pharmacovigilance)
PrimeVigilance
- Beograd
- Stalan
- Puno radno vreme
- PSURs/PBRERs
- PADERs
- ACOs
- DSURs
- RMPs
- QC and review of all written output from the operations team as required
- Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
- In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
- Complete quality documentation of aggregate reports
- Attending kick off meetings with new clients as required
- Attending audits and inspections as required
- Providing aggregate report training
- MD, pharmacy or Life Science degree (Masters or PhD is desirable)
- Strong previous experience in Pharmacovigilance (case processing, signal detection or risk management) within ideally a CRO environment
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Ability to effectively train and mentor Associate Medical Writers
- Must be a strong team player
- Fluency in English, an additional language is a benefit
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships