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PV Physician

Employer
CK Group
Location
East Coast
Salary
Competitive
Closing date
11 Mar 2021

Job Details

CK Group are looking for a Pharmacovigilance/Safety Physician to join a very exciting, forward thinking and growing biotech who work within Gene Therapy. This role will have a unique opportunity to join a company in an exciting phase that has the ability to transform the clinical management of ocular disorders.

Location:

Remote based from their US East Coast office.

Salary:
Competitive base salary plus bonus and company shares.

Brief:
Our client is looking for someone who is has passion for patients and who genuinely wants to change their lives for the better. The role of Pharmacovigilance/Safety Physician will be a vital contributor.

PV Physician Role:
  • Advance and maintain the safety governance oversight for all products.
  • Build and manage a high-growth pharmacovigilance team, including recruitment, training, assessment, monitoring and development. Communicate company/departmental information effectively to team.
  • Provide global strategic leadership by setting clear expectations & providing hands-on leadership for PV, promoting collaboration and team cohesiveness.
  • Oversee all PV-related activities performed by external suppliers/consultant, ensuring appropriate documentation and governance frameworks are in place.
  • Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
  • Lead process improvement within global pharmacovigilance - including technology assessment and implementation.
  • Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of clinical study protocols, development plans, INDs/CTAs and serious adverse event handling and all other PV issues, as appropriate.
  • Oversee aggregate reporting, management of risk-benefit profiles, signal detection and risk management and mitigation plans for clinical and post-marketing compounds.
  • Directly oversees the PV staff and operations (including external resources and outsourced PV functions) globally to ensure high quality case processing and aggregate reporting consistent with quality performance metrics.
  • Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical organization for writing and statistical staffing; medical affairs for epidemiology project needs).
  • Ensure PV staff are able to meet safety monitoring needs based on regulatory requirements and company standards for pharmacovigilance and are audit-ready.
  • Oversee development of training modules and provide training in Pharmacovigilance across the Company.

Your Background:
  • MD, degree or equivalent.
  • A proven experience within pharmaceutical industry experience, including in pharmacovigilance management roles.
  • Team player who is able to prioritise workload in a fast-paced environment.
  • An individual willing to embrace the companies culture, and work to instil the values of the Department within their working relationships.

Full job description available upon request.

Apply:
For more information or to apply for this Pharmacovigilance/Safety Physician position, please contact Rob Angrave on +1 (617) 6922948 or email rangrave@ckgroup.co.uk, quoting job ref 49869.

It is essential that applicants hold entitlement to work in the USA.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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