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24 Jul 2019

Full-Time Pharmacovigilance-Quality, and Compliance Training-Senior Manager

meg.graham – Posted by meg.graham Anywhere

Job Description

Minimum Requirements
Experience / Skills:
o Bachelor’s degree in a scientific, allied health field or related field required, advanced degree preferred
o Minimum of 7+ years of relevant work experience required.
o Minimum of 5+ years of progressive experience serving in a Quality role in the pharmaceutical/biotechnology or related industry dealing with Good Pharmacovigilance Practice (GPV) activities, including quality related matters, and experience in conducting audits and hosting GPV regulatory inspections.
o Demonstrates broad and deep expertise related to understanding the principles and application of quality and regulatory compliance.
o Strong knowledge of worldwide regulations pertaining to GPV for pharmaceutical products, including FDA, ICH and EU GVP; PMDA a plus.
o Strong knowledge and experience in auditing and inspections, including development of responses.
o Prior experience in the management, development and implementation of a risk-based global PV & QA Audit program in support of clinical safety and pharmacovigilance activities.
o Advanced knowledge of quality management systems, including systematic approaches to process improvement required.
o Knowledge regarding the use of electronic systems in a regulated environment, including those implemented in support of drug safety, training oversight, and documentation management.
Preferred Skills/Qualifications:
o Strong oral and written communication skills
o Advanced analytical skills
o Sound medical judgment and decision making capabilities
o Strategic thinking and facilitative leadership
o Fluent utility of office computer programs such as Excel, Word, and PowerPoint
o Sound organizational and prioritization skills
o Formal training in Epidemiology a plus
o Demonstrated skills for project management
o Excellent written, communication, and presentation skills.
o Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
o Demonstrated leadership and project management skills.
o Advanced ability to effectively communicate and influence the outcomes of the decision-making process.
o Displays highly developed organizational leadership qualities.
o Must demonstrate a keen attention to detail and timelines.
o Demonstrated leadership and project management skills.
o Demonstrated ability to stay abreast of trends and new information in the profession.
o Ability to maintain a high level of ethical and compliancy standards.
Organizational Relationship/Scope:
o Position will report directly to Vice President of Global Patient Safety & Risk Management. Individual is expected to work independently with support from management and colleagues in GPV. This individual will communicate and collaborate with GPV subject matter experts to optimize departmental compliance and quality.
Working Conditions:
Working conditions: normal office setting.
Location: Bedminster, NJ
Travel: Occasional for training, professional conventions, corporate meetings.

Job Types: Full-Time.

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