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.
- 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.