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Associate Director, Pharmacovigilance Quality Operations - Switzerland
Posted on : 01 May 2017
This position will develop, implement, and support quality and compliance standards in the Global Pharmacovigilance, Regulatory, and Medical Information spaces in compliance with global regulatory requirements and company standards.
- Support CAPA development with cross-functional teams and serve as quality approver
- Track global CAPA progress and evaluate evidence for CAPA closure to ensure compliance with company and regulatory standards
- Support GPV process development and serve as quality approver for relevant controlled documents
- Ensure inspection readiness in the GPV, Regulatory, and Medical Information areas including SME training/preparation, inspection strategy, and back room/front room support activities; work with the R&D Audit and Inspection function to analyze risks and develop inspection readiness strategy, with particular focus on European agencies and regulators
- Coordinate quality inputs for PSMF and partner with GPV team and other quality units to support maintenance and compliance of PSMF on an ongoing basis
- Collect and monitor compliance metrics globally and evaluate possible trends
- Contribute quarterly metrics for quality management review
- Provide consultation to for possible quality issues, lead quality investigations and support completion of root cause analysis
- Provide input to corporate audit planning
- Establish partnership with corporate and affiliate quality units, with attention to harmonization of affiliate quality activities
- Minimum of 10 years of experience in GCP/GPV or GCP/GVP quality assurance
- Quality, processes, and compliance oriented
- Knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) pertaining to pharmacovigilance
- Solid knowledge of IT structure and Information Database Systems (such as Oracle Argus, Trackwise)
- Ability to write standard operating procedures
- Ability to manage multiple projects and priorities
- Bachelor’s degree in life science required (PhD or PharmD preferred)
- Excellent communication and negotiation, customer service oriented, and interpersonal skills
- Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment
- Results oriented, accountability, and delivery
- Strong interpersonal skills while building/keeping/monitoring quality and compliance
- Multitasks and ability to manage multiple global processes
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders.
- Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- In addition, company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.