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Senior PV Manager (remote-based)

Employer
Hobson Prior
Location
Homeworking
Salary
£55000 - £60000 per annum
Start date
27 Apr 2021
Closing date
25 May 2021

View more

Discipline
Clinical Research, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Hobson Prior are currently working with a leading CRO who are recruiting for a Senior PV Manager to join them on a permanent basis, where you will be required to work remotely. Our client is focused on providing clinical development solutions for the biotech and pharmaceutical industries.

Job Responsibilities
:

  • Accountable to lead the pharmacovigilance team.
  • Maintains awareness of and adherence to the schedule of established project and process timelines.
  • You will establish and measure set of metrics applicable for PV performance.
  • Manages the budget of the pharmacovigilance services.
  • Develops Safety Management Plans for the clinical trials.
  • Provides inputs to project design, establishes and implements the project's safety strategy.
  • Prepares and maintains Standard Operating Procedures fulfilling all relevant law regulations and describing an appropriate and effective pharmacovigilance system.
  • Develops and improves working instructions, guidelines, standards for PV team covering case processing (case review, quality control, electronic database entry, follow-up activity, queries and narrative writing, reconciliation), safety reporting (preparation, quality control and submission of periodic and expedited reports to Competent Authorities, Ethics Committees).
  • Assists sponsors in Development Safety Update Report writing, compilation and submission of the report to the competent authorities within the time frames declared by the pharmaceutical laws and effective regulations.
  • Initializes urgent actions whenever required.
  • Shares PV knowledge and experience with the organisation's personnel.
  • To provide support to the Commercial Project Support department.
  • To provide general PV training for all company employees.
  • Develops PV knowledge by participating in external trainings and by self-training.
  • Maintains good relationships with sponsors, local Competent Authority and Ethics Committee.
  • Any other assigned duties.

Key Skills:

  • Good planning, organization and problem solving abilities.
  • Good communication and interpersonal skills.
  • Good analytical and negotiation skills.
  • Computer competency.
  • Fluent in local office language and in English, both written and verbal.

Requirements:

  • University/college degree (life science preferred).
  • At least years of clinical research experience (minimum 1 year in pharmacovigilance).
  • Very good knowledge of GVP, GCP, local regulatory requirements, ICH Guidelines, European Directives.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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