Pharmacovigilance Operations Leader

Pharmacovigilance Operations Leader

ProductLife Group

Cambridge, United Kingdom

As a result of an increase in workload we are now seeking a Pharmacovigilance Operations Leader responsible for planning, organising and managing delivery services and human resources in order to deliver high quality services (within time and budget) and to obtain a long-term relationship with clients.

Primary Responsibilities

  • Contribute to current and future Pharmacovigilance and Medical Writing domain offerings in cooperation with Head of Safety and Medical Platforms;
  • Provision directly or by delegation of adequate subject matter support to enable sales and marketing functions to discharge their responsibilities;
  • Personally, capable of delivering service to domain clients at a senior professional level;
  • Responsible for all projects/programs/engagements in her/his domain, including client contacts (if needed) in their department in order to meet and even exceed client expectations;
  • Act upon when issues are escalated;
  • Ensure that client feedback is collected and managed (including CAPA);
  • Assume role of EU QPPV and/or Graduated Plan Officer (as required);
  • Act as Local Safety Officer (as require);
  • Day to day management of members of his/her team;
  • Planning of human resource requirements within the domain;
  • Liaise with other Platform Leads for resource planning and forecasting;
  • Management of individual staff performance with the support of Head of Safety;
  • Coaching and motivating team members ensuing the team have the right support and training needed;
  • Identification and development of tools to support and manage key performance are collected and reviewed with respect to pre-defined targets on a regular basis with the Head of Safety and Medical Platforms;
  • Annual staff performance reviews;
  • Develop process capability within her/his area of expertise;
  • Responsible for oversight of SOP/WPD support;
  • Identification of gaps or new areas that require SOP/WPD support;
  • Accountable for expenditures directly associated to dedicated tools, subscriptions, training and development.

Candidate Profile

Education and Experience

  • Masters or higher graduate degree in a science related field, or equivalent experience;
  • Knowledgeable in post marketing PV and should have experience in managing PV teams;
  • Minimum of 10 years in PV, past line management experience is essential;
  • Experience in PV, Legislation and Operations;
  • Knowledge of Clinical Trials directive (CTD), GVP Modules in depth, local legislation and all PV documents (RMP, PSUR, PSMF, signal detection).

Key skills

  • Ability to mentor and coach staff;
  • Manage group resourcing and project allocation;
  • Ability to perform EU QPPV, graduated plan Officer roles would be an advantage not essential;
  • Ability to work in several different teams, departments and stakeholders within PLG Group;
  • Excellent communication, planning and organisational skills;
  • Fluent verbal and written English language skills for daily contacts with local and international partners, other EU languages would be an advantage.

Core Competences

  • Good problem-solving skills;
  • Team player;
  • Excellent organisational skills;
  • Good interpersonal skills.

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© EuroJobsites 2019

EuroJobsites is a UK 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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