Associate Director, Pharmacovigilance & Deputy QPPV

Highly Competitive Salary
16 Sep 2017
14 Oct 2017
Contract Type
Full Time

ProClinical is seeking an Associate Director Pharmacovigilance/ Deputy QPPV for a global pharmaceutical company. The Associate Director, Pharmacovigilance/ Deputy QPPV helps run a seamless pharmacovigilance capability, that ensures safety is at the heart of everything the company does. The role requires an aptitude and willingness to have direct, hands-on involvement in the delivery of key projects and contributes more broadly to the European HQ, as well as interacting with the wider organisation. This is a permanent role based in the London Area.

Job Responsibilities:

  • Participate in local or global project teams as a subject matter expert in PV
  • Participate in company Signal Management activities; contribute to identification and evaluation of safety signals from all available sources
  • Participate in the timely planning, execution, submission, implementation and maintenance of EU RMPs, periodic aggregate safety reports (PSURs/PBRERs and DSURs) and ad hoc safety reports
  • Participate in the creation of response documents to EU Regulatory Authorities in cooperation with the QPPV and other colleagues as appropriate
  • As Deputy QPPV, support the QPPV function within the company and globally, ensuring constant compliance with European PV Legislation and European Regulations and maintaining the company's Pharmacovigilance system
  • Help to maintain a robust Pharmacovigilance compliance programme, company policies and Standard Operating Procedures (SOPs) and ensure compliance with regulatory standards is fit for the European business
  • Assist in building good working relationships with other departments, both globally and at European level, to ensure all PV-related activities are fully understood and carried out in timely manner
  • Assist in the implementation of compliance standards and facilitate the regular collection of compliance metrics as required
  • Maintain PV agreements, contracts, Safety Data Exchange Agreements (SDEAs), pre-audit questionnaire and data analysis relevant to the company's quality compliance programme
  • Constantly maintain inspection readiness for PV and GCP audits and inspections; take part in the preparation and help conduct Pharmacovigilance inspections/ audits and contribute to GxP inspections/ audits, as necessary; support timely execution and submission of responses to inspections/ audits findings; maintain inspection/audit related documentation and PSMF files containing audit reports, responses
  • Prepare training materials and deliver Pharmacovigilance training for European employees, ensuring company training and training attendance log is kept and training folders are maintained by European PV personnel
  • Assist in the management of PV activities at affiliate level, in line with the company's corporate procedures
  • Other tasks assigned by the Functional Head, as needed

Skills and Requirements:

  • Degree in relevant subject x Medical degree x Post graduate specialisation x Experience
  • Min 5-10 years' experience in the pharmaceutical industry, predominately in Pharmacovigilance, having worked on both development and marketed products
  • Experience in the role of (Deputy) QPPV
  • Experience of working in a cross functional team
  • Knowledge, competencies and skills Proven expertise in Pharmacovigilance, including risk management - understanding, identifying, mitigating and communicating risks at the study or program level
  • Advanced knowledge of regulations governing Pharmacovigilance in the pharmaceutical industry and Research & Development processes in Europe and globally
  • Strong organisational, planning, prioritising and problem-solving skills
  • Effective multi-tasking skills, applied in different and complex assignments and ability to work effectively under the pressure and under strict timelines
  • Ability to work both independently and collaboratively and use own initiative
  • Ability to communicate effectively both locally and globally, internally and externally
  • Proficient MS Office skills
  • Experience in working with Japanese companies
  • Personality and attitude
  • Approachable, flexible and self-motivated
  • Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements
  • Tolerance for ambiguity and ability to adapt quickly to a changing business environment
  • Highly resilient, tenacious and resourceful
  • High attention to details

To Apply:

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