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Senior Pv Specialist, Office of The Qppv
Il y a 4 mois
The Senior PV Specialist is part of the Office of the Qualified Person for Pharmacovigilance (QPPV) reporting to the Deputy QPPV or QPPV Office Physician, and is responsible for supporting through oversight, participation and partnership the many varied activities related to the role of the QPPV.
The Senior PV Specialist supports the management of the Pharmacovigilance System Master File (PSMF) requiring interface with numerous key internal stakeholders including Global Safety Headquarters, and other applicable business units across the company, plus direct interaction on behalf of the QPPV with external PV inspectors.
In addition, the role requires ad-hoc liaison with the EMA and other agencies as well as PV inspectors on matters related to regulatory compliance in pharmacovgilance.
This position also provides support to the QPPV for specialist project in pharmacovigilance.
Your profile:
- Education: a bachelors degree, preferably in biological science, nursing or pharmacy.
- Direct experience and associated proven training in pharmacovigilance is required.
**Experience**:
- Working knowledge of EU requirements related to the pharmacovigilance relating to the QPPV role and remit required.
- At least three years of experience in a hospital, pharmaceutical or research position, including a minimum of eighteen months in a drug safety position. Must be able to effectively organise scientific information.
- The incumbent is expected to have strong communication, problem-solving and presentation skills, along with a demonstrated ability to build and manage close relationships with key stakeholders.
- IT literacy.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:06/30/2024
**Requisition ID**:R291117
