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Peraton

Alaska Workstream Product Owner

Anchorage, AK · On-site

We are seeking an Alaska Workstream Product Owner to join our team of qualified, diverse individuals. The ideal candidate will serve as the primary liaison between FAA stakeholders, engineering teams ...

Workstream

NY

$56K - $77K/yr

Workstream is seeking a motivated Restaurant General Manager in the Town of Huntington, NY. The role involves overseeing restaurant operations, leading a strong team, and ensuring excellent customer ...

Workstream

$50K - $69K/yr

Workstream, located in Pine Forest, Florida, is looking for a dedicated Restaurant General Manager to lead daily operations, drive sales growth, and maintain high standards of food quality and ...

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Infographic showing various job openings at Workstream in the United States as of June 2026, with employment types broken down into 84% Full Time, and 16% Part Time. Highlights an 89% Physical, and 11% Remote job distribution.

Associate Director/Director - Pharmacovigilance Workstream Lead

PharmaLex

Malvern, PA • Remote

Full-time

Posted 26 days ago

Job description

Associate Director/Director - Pharmacovigilance Workstream Lead
Job purpose
  • 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.

Main tasks
Workstream Leadership:
  • 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.

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 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.

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-related 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 all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related 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-related activities, or any other status protected under applicable federal, state or local law.

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