Ofertas de empleo en PrimeVigilance

• Nivel de experiencia---
• Tipo de contratoA tiempo completo
• Publicada22 ago.

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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.

Job Description

For the Client (May include but is not limited to the following):

To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and company causality, as well as writing of company comment, follow-up questions and analysis of similar events, when required. Including completion of all required supporting documentation such as trackers.

To review literature screening search strategy

To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product

or other safety related findings

Reviewing database outputs

To review and provide input in Periodic Safety Update Reports

To review and provide input in Development Safety Update Reports

Participating in signal detection activities including meetings and writing signal detection reports

Proposing a course of action whenever a possible signal is identified

For the Company (This may include but is not limited to):

Writing PV Procedures

Mentoring less experienced Physicians

Qualifications

• Medically qualified as a physician with demonstrated experience in Pharmacovigilance
• Any experience in aggregate reports and signal detection is desirable
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
• Communication skills
• Presentation skills
  
  

• 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