Pharmaceutical / Biotech

PV STRATEGY MANAGER/SR MANAGER 

San Francisco, CA

EXP 2-5 yrs

DEG Bach

BONUS

Job Description.

PV Strategy Manager/Sr Manager-

The PV Strategy Leads are responsible for the development and implementation of a risk-based quality assurance strategy that covers all PV processes and activities performed by Pharma global functions, Affiliates, service providers and licensing partners. This role conducts risk assessment to deliver an audit program, provides strategic direction to audit operations, and provide actionable data to senior management based on analysis of compliance data and identification of trends.

• Define/maintain the audit and risk universe of PV processes/activities and perform risk assessment to determine annual audit plan; define and maintain risk assessment methodology and related procedures and tools

• Assess data/metrics from PV audits, inspections, regulatory intelligence and risk management activities by the business functions for compliance trends and risks; develop communication tools for audits and inspection metrics and trends

• Define audit scope for internal process and licensing partner audits, review audit plan, audit reports which contain a PV component, and assist evaluation of CAPA as assigned; act as a point of contact for internal process PV and licensing partner audits and support the lead auditor

• Participate in PV audits, and support regulatory authority PV inspections as necessary

• Maintain highest level of awareness, expertise in international PV regulations and internal policies and SOPs; assess impact of new regulations and guidance on PV activities

• Provide quality leadership and direction to PDQ/PDQA and our customers/stakeholders on PV related issues; establish strong partnership with key stakeholders in business functions and represent PDQ/PDQA in cross-functional governance teams

• Participate in or lead department or cross-functional compliance projects and initiatives as assigned; assist and/or contribute to the development and execution of PDQ/PDQA goals.

• Bachelor’s degree or equivalent in scientific or quality-related field with significant experience in pharmaceutical industry and/or quality assurance. Proficiency in the conduct of PV audits desired.

• Experience in pharmacovigilance, with demonstrated applied knowledge of pharmacovigilance and international pharmacovigilance regulatory requirements and guidance

• Experience in compliance program or project management, with demonstrated analytical, organizational and planning skills

• Proven demonstration of leadership, strategic and system thinking

• Demonstrated problem solving and decision-making skills

• Ability to work effectively in an international multicultural matrix organization; highly effective team work and collaboration skills

• Demonstrated ability to effectively communicate, influence and lead both with and without authority; fluency in written and spoken English

All your information will be kept confidential according to EEO guidelines.

Direct Staffing Inc