Pharmacovigilance Senior Scientist / Manager

Location: Wimbledon, London

Main Responsibilities:

  • You will lead a unique project, working directly with a long-standing client, conducting regular safety surveillance activities for assigned products.

  • You will lead activities conducting authoring of Pharmacovigilance reports including PBRERs, DSURs, Safety Evaluation Reports, cumulative reviews and input into Risk Management Plans, ensuring assigned sections are accurate.

  • You will be involved in providing responses to Health Authorities and/or supporting other team members with internal requests.  

  • Partnering with the client you will demonstrate determination and creativity in identifying and analysing tasks and data, providing innovative solutions.

  • You will ensure that the project meets or exceeds targets within the scope of time constraints.

  • You will manage information and communication ensuring that stakeholders are informed of major risks/opportunities along with any contingency/mitigation plans.

  • You will ensure data integrity, and take responsibility for tracking and documenting issues to resolution.

  • You will liaise with finance on client invoicing and billing throughout the project lifecycle.

  • You will support inspection readiness oversight and prepare and implement action plans working collaboratively with group members.

 

About you.

  • A minimum of a Bachelor’s degree in scientific domain.

  • A minimum of 5+ years Pharmacovigilance industry experience within a pharmaceutical company or at a CRO

  • Experience of managing writing teams in Pharmacovigilance domain would be preferential

 

Core Competencies

  • Excellent written and verbal communication skills, including presentation to cross-functional teams
  • Strong MS Word/ PowerPoint/ Excel knowledge
  • Ability to manage time by planning and prioritising deliverables.
  • Analytical capabilities, proficiency and comfort with the analysis of complex scientific data set.
  • Commitment to highest quality outputs, including obsessive attention to detail
  • Ability to be a successful team collaborator, but also self-motivated and able to work independently
  • Knowledge of applicable global and regional regulatory requirements

What we can offer you.

Kinapse can offer you a rewarding and challenging career working with smart, ambitious, yet humble professionals. We pride ourselves on having a non-hierarchical and friendly office culture where people are prepared to go the extra mile to help one another.  If you’re lucky enough to work in our Wimbledon office we have some great social events.  A competitive salary with a range of benefits including life insurance, health, pension and bonus.

To apply, please email your CV to recruitment@kinapse.com


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