Senior Manager, Clinical Quality Assurance (Pharmacovigilance)

Senior Manager, Clinical Quality Assurance (Pharmacovigilance)

GW Pharmaceuticals

Cambridge, United Kingdom

Job Purpose:

To be the Primary point of contact within CQA for all PV quality related activities.

Provide expert GPvP knowledge, support, advice and training to the Pharmacovigilance department and other functions that impact the pharmacovigilance system

KEY RESPONSIBILITIES/ACCOUNTABILITIES:

  • Promotes a culture of quality excellence that encourages ethical conduct and a commitment to compliance, resulting in a positive image to both company and external personnel;
  • Provides strategic input in the development, coordination and implementation of GPvP related quality assurance activities;
  • Supports the Company’s risk based Quality Management System on all levels from design, implementation and execution through life cycle management resulting in a culture of continual process improvement.

DETAILED RESPONSIBILITIES/ACCOUNTABILITIES:

  • Provide insights, analyses and support in the promotion of compliance with global clinical and post-marketing GPvP regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives;
  • Provide guidance, interpretation, support, training, and key input to company groups for consultation and interpretation of regulations, guidelines, corporate standards and policies;
  • Oversee global CAPAs relating to Pharmacovigilance activities ensuring compliance with commitments and including assessment of root cause;
  • Support Quality oversight activities for PV and PV related vendors;
  • Effectively communicate and escalate quality concerns and critical matters to management;
  • Supports the implementation, execution and performance oversight of the PV QMS and PV System for clinical and commercial operations;
  • Reviewing key pharmacovigilance documents, e.g. PSMF, reports, and regulatory submissions;
  • Support;
  • Operates in accordance with the GW corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence;
  • Leads projects to deliver improvements in productivity and efficiency in all areas relevant to PV and CQA;
  • Works in accordance with and champions safe systems of work with regards to health & safety, security and the environment;
  • Leads or participates in other projects, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager/GQLT.

KEY ATTRIBUTES/SKILLS/EDUCATION - ESSENTIAL:

Knowledge:

  • Detailed knowledge of GPvP, knowledge of GCP and GMP international regulations and guidance in relation to clinical trials and post-marketing activities;
  • Typically Bachelor’s degree in science or related discipline;
  • Post-graduate qualifications (Master’s, PhD) preferred.

Experience:

  • Significant, relevant work experience in the Pharmaceutical, Biotechnology or a related industry;
  • PV auditing experience preferred.

Skills:

  • Working knowledge of office IT packages;
  • High level of written and verbal communication skills.

Attributes and Behaviours:

Proven organisational and interpersonal skills, demonstrated through the following competencies:

  • Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services;
  • Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; doesn’t misrepresent him/herself for personal gain;
  • Peer Relationships: Can quickly find common ground and solve problems for the good of all; can solve problems with peers with the minimum of noise; is seen as a team player and is cooperative;
  • Managing through Systems: Can design practices, processes, and procedures that allow managing from a distance; is comfortable letting things manage themselves without intervening; can make things work through others, without being there; can impact people and results remotely;
  • Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience and judgement;
  • Building Effective Teams: Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes; lets people finish and be responsible for their work;
  • Planning: Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops scheduled and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results;
  • Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; creates focus
  • Negotiating: Can negotiate skilfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing;
  • Motivating Others: Creates a climate in which people want to do their best; can motivate many kinds of direct reports and team or project members; can assess each person's hot button and use it to get the best out of him/her; pushes tasks and decisions down; empowers others; invites input from each person and shares ownership and visibility; makes each individual feel his/her work is important; is someone people like working for and with.

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© EuroJobsites 2021

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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