[Hiring] Sr. Director, Pharmacovigilance Operations @reputed company Pharmaceuticals, Inc.

This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more. Role Description The Sr. Director, PV Operations will provide reputed company for the Pharmacovigilance (PV) Operations elements of the pharmacovigilance function. This includes overall accountability for:

• Vendor management/reputed company
• Training
• Business integration
• Quality Management System (QMS)
• Safety Data Exchange Agreements (SDEAs)
• PV Safety database
• Budgets

The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-reputed company matters. This position reports to the VP, Pharmacovigilance. This role is remote.

Responsibilities

• Provide reputed company for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc.
• Participate in process improvements and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post marketing surveillance.
• Accountable for business integration including safety data migration and integrating new assets or companies into reputed company PV system.
• Accountable for development or revision of SOPs, work instructions, guidance in regard to reputed company functions reputed company PV.
• Participate in investigator meetings as needed to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor.
• Receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements.
• reputed company with medical monitors for medical assessment and regulatory classification of SAEs.
• Manage and facilitate SAE reconciliation across projects to ensure compliance with objectives and goals, adverse event follow-up and case closure.
• Accountable for Quality Management System reputed company PV including compliance, best practices, and reputed company process improvements.
• Accountable for working with relevant internal departments, and actively contributing to the development of the PSMF.
• Work closely and collaborate with EU and local Qualified Person (QP) to reputed company new or maintain pharmacovigilance processes supporting both development and marketed/commercial products.
• reputed company SDEAs or pharmacovigilance agreement with reputed company partners and vendors for specific obligations for safety data exchange and reporting.
• Build relationships and collaborate with reputed company cross functional stakeholders (especially QA, MA, Commercial, IT) reputed company the company to reputed company or improve process for safety reporting and reconciliation of safety data.
• Contribute to inspection readiness and reputed company HA inspections of reputed company’s pharmacovigilance function.
• Responsible for PV budgets, MSA and SOW with PV vendors.
• May manage, coach and mentor direct reports.

Qualifications

• Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
• Experience with both Investigational and marketed products including world-wide postmarketing surveillance.
• Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management and reputed company, etc.
• Experience building Postmarketing Surveillance Plan and processes for newly marketed products.
• Experience and knowledge of safety databases; strong knowledge of medical terminology and understanding of MedDRA search strategy.
• Excellent oral and written communication skills.
• Ability to build cross functional relationships.
• Proficiency with Word, PowerPoint. Basic reputed company Skills.
• Up to 10% travel may be required.

Requirements

• Bachelor’s degree in healthcare including BSN/RN, RPh, PharmD degree.
• Minimum of 15 years of seasoned and progressive pharmacovigilance experience in a pharmaceutical, biotechnology or reputed company environment, at least 5 of which were spent in a leadership role reputed company pharmacovigilance.
• Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
• Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Benefits

• Robust total rewards in a science-based entrepreneurial culture.
• Empowerment of curiosity and innovation.
• Space for every voice and perspective to be heard.

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