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Drug Safety / Pharmacovigilance / PV Manager - Freelance, UK

Employer
Planet Pharma Staffing Limited
Location
Slough, Berkshire (GB)
Salary
Competitive Hourly Rate
Start date
14 Aug 2019
Closing date
13 Sep 2019

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Job Details

JOB PURPOSE

The Drug Safety Manager is responsible for leading the project management, planning and implementation of Pharmacovigilance and Risk Management projects within a global team, ensuring oversight, coordination, stakeholder liaison, performance management, issue escalation and resolution in relation to services and activities.

RESPONSIBILITIES

  • Ensuring that the project deliverables are on time, within budget and at the required level of quality.
  • Leading Projects, oversight, coordination, stakeholder liaison, performance management, issue escalation and resolution in relation to Pharmacovigilance services and activities including.
  • Mitigate risk by ensuring adherence to project timelines and applicable regulations and policies terms.

MAIN ACTIVITIES

Project Management:

  • Provides leadership, facilitates decision-making and takes ownership of assigned PV project deliverables.
  • Leads in confirming the definition of project scope, goals and deliverables.
  • Defines project tasks and resource requirements.
  • Develops full scale project plans and a schedule for project completion that effectively allocates the resources to the activities.
  • Serves as primary point of contact for Vendor management and contributes to addressing Vendor activities related issues.
  • Serves as point of contact with senior management for updates and timely escalation of issues that require senior management attention.
  • Leads stakeholder meetings and actions to address continuous improvement opportunities internally.
  • Anticipates, identifies and resolves project related issues in cooperation with the Project Lead and/or other internal/external stakeholders exercising judgment within defined practices and policies.
  • Escalates critical project issues to concerned stakeholders.
  • Recognizes, communicates and addresses change management requirements including changes to applicable Policies/Convention/SOP/WP.
  • Ensures proper record keeping, documentation, analysis and review.
  • Ensuring vendor selection activities across international team are conducted and qualified.
  • Leads and coordinates project activities from vendor selection, project kick off and implementation through steady phase for outsourced PV services.

OTHER RESPONSIBILITIES

  • Lead and manage international projects
  • Decisions within continuous improvement initiatives.
  • Issue Escalation and Corrective and Preventative Actions (CAPA).
  • Deviations from defined process, structure and amendments.
  • Global regulatory compliance & quality standards are achieved.
  • Lead decision making relating to budget associated with vendors, WFP, Goals, reward, promotions etc.
  • Proposals and options for international vendors.

REQUIRED SKILLS

Qualifications

  • Minimum of Bachelor's level degree in life sciences, pharmacy or equivalent required, advanced degree preferred.

Experience    

  • 5-7 years’ experience in Project Manager role
  • Previous relevant experience in the pharmacovigilance and related QC processes required.
  • Project Management relevant experience and competencies.
  • Experience in interacting with Global Competent Authorities.
  • Experience with and demonstrated success in working on cross-functional diverse teams.

LOCATION

West London, United Kingdom (may offer some flexibility to work from home)

DURATION

6-12 month freelance contract with high chance of extension

SALARY

Competitive hourly rate

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)203 868 8607 or e-mail on schapple@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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