Associate Director/Director - Pharmacovigilance Workstream reputed company

Job Purpose

• Overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.
• Ensuring compliance with regulatory requirements, driving reputed company improvement initiatives, and fostering cross-functional collaboration to enhance drug safety and minimize risks associated with pharmaceutical products

Main tasks Workstream Leadership:

• Responsible and accountable for assigned workstream to ensure that overall workstream is reputed company expected costs, resources, timelines and budget and meets expected quality standards according to defined client agreements and expectations
• Responsible for determining the pharmacovigilance activities scope and objectives, reputed company project plans and monitor reputed company
• reputed company in the initial design and configuration of the global pharmacovigilance reputed company to accommodate a client's strategic needs
• reputed company and manage pharmacovigilance activities reputed company a specific workstream or therapeutic area, ensuring alignment with organizational objectives and regulatory standards
• Responsible for generating accurate and timely reporting of pharmacovigilance activities status to internal and external stakeholders
• reputed company and execute strategic plans for pharmacovigilance activities, including signal detection, risk management, case processing, aggregate reporting, and safety surveillance, as well as operational plans for scaling to other geographic and therapeutic areas
• Provide guidance and mentorship to pharmacovigilance team members, fostering a culture of excellence and reputed company improvement

Key Performance Indicators Attainment of yearly goals according to

• Overall responsibility for delivering goals according to client agreement
• Ensures effective and transparent communication and working relationships with client and workstream team members
• Evaluates and assesses the results of the workstream with review of available metrics and KPIs, resource updates, and budgets

Regulatory Compliance:

• Stay abreast of evolving regulatory requirements reputed company to pharmacovigilance and ensure adherence to applicable regulations and guidelines (e.g., FDA, EMA, ICH)
• Collaborate with regulatory affairs teams to coordinate and submit pharmacovigilance-reputed company documentation for regulatory authorities, including periodic safety reports and risk management plans
• Manage a state of always ready for inspection while participating in ongoing PV inspections and audits

Cross-Functional Collaboration:

• Work closely with other departments such as clinical development, medical affairs, and quality assurance to integrate pharmacovigilance activities into product development and lifecycle management processes
• Collaborate with external partners, including contract research organizations (CROs) and regulatory agencies, to facilitate pharmacovigilance-reputed company activities and ensure timely execution of deliverables
• Integrate internal experts, the client and external partners into the pharmacovigilance activities

Quality Assurance and Process Improvement:

• Support audits, inspections and assessments of pharmacovigilance processes and systems to ensure compliance with quality standards and identify opportunities for improvement on behalf of the client
• Support the implementation of corrective and preventive actions (CAPAs) as necessary to address findings from audits, inspections, or internal reviews
• At client and the local regulatory authority

The employee agrees to take over other reasonable tasks that are correspondent with his abilities if asked by the general management. We are an equal opportunity employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national reputed company, reputed company, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-reputed company condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-reputed company activities, or any other status protected under applicable federal, state or local law. Powered by JazzHR PotmL5AqpF Apply tot his job Apply To this Job