Deputy Qppv

No Relocation Assistance Offered
154328 - Colombes, Top-of-Seine, France

Deputy QPPV

EU - Fully Remote Position - Must reside in EU

In order to continue its commercial success, Colgate-Palmolive is currently looking for a Deputy QPPV (fully remote/home office based in EU). The Deputy QPPV supports a seamless pharmacovigilance capability that ensures safety as a top priority for Colgate-Palmolive’s product line of drugs/medicines, medical devices, cosmetics and general products. The role requires an aptitude and willingness to have direct, hands-on involvement in the delivery of key projects globally. This is a permanent role and is home-based within the EEA with expected, targeted travel for training, on-boarding and company needs.

Job Responsibilities:

- Knowledge and working practice of the EU Good Pharmacovigilance Modules (GVP)
- Participate in company Signal Management activities; contribute to identification and evaluation of safety signals from all available sources
- Knowledge of Brexit and its impact on PV systems
- 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 stakeholders
- As Deputy QPPV, support the QPPV function within the company and globally, ensuring constant compliance with European PV Legislation, EU 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
- Maintenance and support of the PV System Master File
- 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 successfully executed
- Assist in the implementation of compliance standards and facilitate the regular collection of compliance metrics as required
- Maintain/Oversee PV agreements, contracts, Safety Data Exchange Agreements (SDEAs) 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 properly documented and stored
- Support in the management of PV activities at affiliate level, in line with the company’s corporate procedures
- Other tasks assigned by the GPV Head, as needed

Skills and Requirements:

- Doctorate in Medicine or Pharmacy, preferred, other health care professionals considered
- Min 5-10 years' experience in the pharmaceutical industry, predominately in Pharmacovigilance, having worked on both development and marketed products
- 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
- 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

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under