Pharmacovigilance (PV) Quality Manager

- Facilitate the vision and strategy for inspection and audit readiness worldwide and provide direction through policy/procedure development and deployment, including training.
- Act as a contact and resource globally during regulatory inspections by competent authorities, including facilitating interviews with appropriate subject matter experts. Must be able to assimilate large amounts of data efficiently, exercise sound judgment, and maintain composure in order to effectively handle sensitive issues and stressful situations.
- Assist in the assembling of cross-functional teams in preparation for and to compile responses to regulatory agency inspections and internal/external audits and assist colleagues during the course of inspections and audits.
- Actively participate in PV inspections and audits and/or remotely help to make PV inspections a success, including acting as host, scribe and document controller. Support the resolution of findings. Ensure and provide consultation and effectively communicate solutions/responses to compliance issues/questions to stakeholders to be in a continuous state of compliance with worldwide regulatory requirements. Assists with/lead the preparation and communication of audit report findings including periodic trend assessments.
- Assess the changing environment during an inspection and facilitate as needed to ensure the most beneficial outcome. Decisions must be made promptly, with clear understanding of their future impact on operations.
- Collaborate across the organization to facilitate the drafting of corrective/preventive action (CAPA) plans in response to audits and inspections and ensure that commitments are met in a timely manner. Assess on-going compliance of the corrective action plans submitted to regulatory agencies, identify gaps and bring them into compliance.
- Act as the QST partner to facilitate, progress and close CAPA and commitments arising from regulatory inspections and internal audits, as appropriate.
- Evaluate audit/inspection reports from various sources (eg, regulatory agencies, other Company quality groups) to identify issues of significance and report trends.
- In collaboration with the Procedural and Training groups, develop and update documents (SOPs, business procedures) relating to inspections and audits in responses to audits and inspections and quality initiatives.
- Participate in/facilitate a continuous improvement process to optimize the PV quality system and keep it current, based on applicable worldwide regulations.
- Facilitate/Lead the development of inspections readiness tools and support the implementation of the PV inspection readiness program.
- Serve as a consultant to business partners and contribute in building positive and value-added relationships with all stakeholders and help these stakeholders create strategies to respond to regulatory findings and other requests from regulatory authorities.
- Participate on/lead cross functional teams to execute on process improvements identified through the audit (or inspection) process.
- Assist with efforts to drive continuous improvement efforts (quality, cost, speed, performance).

Education/Experience:
- Education to Masters level or BS with commensurate experience in inspections, audits, compliance
- 5-7 years minimum experience focusing on Pharmacovigilance, Regulatory Affairs or within a Health Authority.
- Extensive knowledge of the pharmaceutical industry including Pharmacovigilance and ICH compliance regulations and guidelines and expertise within the pharmacovigilance, inspection, audit, or compliance arena.
- Safety, Regulatory or Clinical development and business experience in order to have a thorough understanding of the processes associated with safety and regulatory operations.
- Ability to effectively collaborate across a range of stakeholders.
- Effective written and oral communication and interpersonal skills, facilitation, negotiation, and influencing skills with an demonstrated ability to lead projects, initiatives, or programs across multiple departments, regions and business units and external stakeholders.
- Knowledge of Safety reporting systems and technologies.
- Ability to multi-task, bridge cross-functional communication gaps, and prioritize workload.
- Excellent project management skills, including effective planning and organizational skills, attention to detail and excellent follow through and ability to handle multiple issues on multiple projects simultaneously.
- Awareness of the key differences in how business is practiced in various countries to work effectively with various cultures.
- Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, PowerPoint, Visio, etc.).
- Experience collaborating or interacting with health authorities (including but not limited to the US FDA, EMA, MHRA) or with other global regulators is highly desired.
- Experience with CAPA tracking tools a plus.

SKILLS
Synectics is an Equal Opportunity Employer.