PharmaLex · 12 hours ago
Associate Director/Director - Pharmacovigilance Workstream Lead
Malvern, PA
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
Maximize your interview chancesBiotechnologyConsulting
Insider Connection @PharmaLex
Get 3x more responses when you reach out via email instead of LinkedIn.
Responsibilities
Overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.
Ensuring compliance with regulatory requirements, driving continuous improvement initiatives, and fostering cross-functional collaboration to enhance drug safety and minimize risks associated with pharmaceutical products.
Responsible and accountable for assigned workstream to ensure that overall workstream is within 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, develop project plans and monitor progress
Lead in the initial design and configuration of the global pharmacovigilance framework to accommodate a client's strategic needs
Lead and manage pharmacovigilance activities within 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
Develop 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 continuous improvement
Stay abreast of evolving regulatory requirements related 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-related 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
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-related activities and ensure timely execution of deliverables
Integrate internal experts, the client and external partners into the pharmacovigilance activities
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
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Overseeing the pharmacovigilance activities of a designated workstream or therapeutic area team.
Ensuring compliance with regulatory requirements, driving continuous improvement initiatives, and fostering cross-functional collaboration to enhance drug safety and minimize risks associated with pharmaceutical products.
Responsible and accountable for assigned workstream to ensure that overall workstream is within 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, develop project plans and monitor progress.
Lead in the initial design and configuration of the global pharmacovigilance framework to accommodate a client's strategic needs.
Lead and manage pharmacovigilance activities within 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.
Develop 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 continuous improvement.
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.
Stay abreast of evolving regulatory requirements related 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-related 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.
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-related activities and ensure timely execution of deliverables.
Integrate internal experts, the client and external partners into the pharmacovigilance activities.
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.
Company
PharmaLex
PharmaLex provides specialized services for the pharma, biotech, and medtech industries.
Founded in 1998
1,001-5,000 employees
H1B Sponsorship
PharmaLex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2022-09-12Acquired· undefined
Leadership Team
Thomas Dobmeyer
CEO and Managing Partner
Company data provided by crunchbase
