Associate Director, Pharmacovigilance Compliance

Associate Director, Pharmacovigilance Compliance

GW Pharmaceuticals

Cambridge, United Kingdom

About the Role:

Responsible for the management of pharmacovigilance (PV) compliance for GW’s medicinal products in both the pre- & post-marketing setting. Actively ensure PV compliance for all aspects of the global PV system in accordance with GPvP/GCP requirements. Address audit and inspection findings by implementing timely and robust CAPAs and process improvements. Ensure inspection readiness. Provide leadership and direction for the global Pharmacovigilance team in collaboration with senior management. Line management of direct reports within the PV Compliance group.

Responsibilities:

  • Track and maintain compliance with regulatory timelines and submission requirements;
  • Work closely with the Operations and Safety Evaluation groups to ensure compliance with relevant regulatory and internal company requirements;
  • Responsible for overseeing contracts and agreements relating to PV, including creation of new and updating of existing contracts/agreements;
  • Overseeing compliance of PV vendors with internal company requirements and standards;
  • Liaising and working closely with the Clinical Quality Assurance (CQA) team to determine the audit schedule and contribute to the audit program;
  • Ensuring a compliant and accurate Pharmacovigilance System Master File (PSMF) that accurately reflects the GW PV system and provides oversight to the GW EU QPPV (and other key PV personnel);
  • Ensure the provision of regular and ongoing EU QPPV oversight of the compliance of the PV system, including formal documentation;
  • Overseeing PV training, documentation and tracking. Maintaining training curricula for the GW PV department globally;
  • Overseeing PV compliance awareness and input of activities undertaken by other GW departments with impact on the PV system (includes, but not limited to, market research, patient support initiatives);
  • Responsible for ensuring that SOPs, Guidelines, Forms and templates accurately reflect current and compliant PV processes;
  • Maintaining a strong GPVP & GCP knowledge;
  • Establishes priorities, sets goals and tracks outcomes for PV Compliance. Ensure appropriate distribution of work within the team and monitor workloads regularly;
  • Provides direction and makes operational decisions on departmental matters in combination with senior management;
  • Makes presentations to senior management/executive level colleagues, as required;
  • Deputise for Senior Director, Pharmacovigilance, as required.

Requirements:

  • Strong background in drug safety/pharmacovigilance with previous experience in the area of PV compliance management;
  • Full understanding of clinical trials and the drug development process;
  • Life sciences degree;
  • Previous line management experience;
  • Thorough knowledge of safety regulations and legal requirements;
  • Proficiency in safety databases, and producing submissions metrics;
  • Excellent communication skills including the ability to work with, influence and direct people at all levels;
  • Excellent organisational and time management skills;
  • Ability to be proactive, work on own initiative as well as part of a team;
  • Excellent attention to detail;
  • Have the ability of prioritising, planning and organising workload;
  • Maintain a positive working environment within the office;
  • Demonstrate a “can do” approach;
  • Demonstrate highest level of confidentiality and discretion;
  • Willingness to travel if required.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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