Senior PV Scientist

Berkshire  ‐ Onsite
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Description

Responsibilities include:

Signal Detection, Evaluation and Labelling

Regulatory Reports and Submissions
  • Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and senior clinical team physician.
  • In partnership with the GSP, provides the clinical safety input into Clinical Development planning activities.
  • Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental compounds and/or marketed products.
  • May provide input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
  • Reviews and provides technical insight to investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters.
  • May present safety information at clinical investigator and commercial meetings.
  • Contributes to and/or reviews the PS component of contracts/agreements with third parties (e.g. collaborators, development partners) and escalates any deficiencies to the respective Skills Director to ensure quality and integrity of agreement.
  • Advises on the preparation of licensing agreements in therapeutic area of responsibility.
  • Participates (along with GSP) in internal meetings with project focus.
  • Participates in external non-regulatory meetings including those with consultants and other companies such as licensing partners.
  • May assist in due diligence activities.
  • Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
  • Participates in, and may lead, a process improvement initiative team within PS.
  • May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
  • Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.


Requirements - Education and Experience

Essential
  • A life sciences/pharmacy/nursing degree, with at least 3 years Patient Safety and/or Clinical / Drug Development experience, with a background working cross-functionally within pharmacovigilance, medical information, medicines management, pre-clinical or clinical research.
  • Demonstrable professional excellence - adds value by applying expertise proactively
  • Good attention to detail
  • Good time management
  • Fluent in English
  • Computer literate
  • Comprehensive understanding of Patient Safety regulatory obligations
Start date
03/2015
Duration
6 Months
From
Real Staffing
Published at
05.03.2015
Project ID:
862301
Contract type
Freelance
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