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Pharmacovigilance Medical Writer II

0 years

0 Lacs

pune maharashtra india

Posted:19 hours ago| Platform: Linkedin logo

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Skills Required

pharmacovigilance service support biotechnology training development writing qc scheduling reports compliance documentation audits report processing signal risk management diversity integrity drive agility collaborative

Work Mode

On-site

Job Type

Full Time

Job Description

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.We are looking for a pharmacovigilance medical writer to join our team. The Medical Writer will be responsible for medical writing including:
  • 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

Qualifications

  • 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
Additional Information

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We Offer

  • 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
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.

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