Sr Manager/Assc Director, Drug Safety/PV Operations (Marketed Products) – NC Pharma/Remote Option

Job Type: 
Professional Services
Other Professional Positions
Life Sciences
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a successful and expanding specialty pharmaceutical company headquartered in Research Triangle Park, NC, is actively recruiting for a highly skilled and capable Drug Safety leader to drive all Pharmacovigilance and Drug Safety operations.

This is an important and impactful position and Company will pay industry-leading wage to attract the right candidate. Client is open to remote candidates, with East Coast candidates strongly preferred.

Key Things to Note:

  • This Company has an impressive portfolio of marketed products, a rich and expanding pipeline and aggressive plans for growth. This Sr Manager/Assc Director (client is open to both levels) will focus on marketed products but may get involved with development products in the future. 
  • The company heavily relies on 3rd party vendors/CROs. Seek candidate accustomed to directing and managing Drug Safety operations in an outsourced model.
  • This is a metrics-driven role and company.  Familiarity with analytical tools and bkgd in Safety/PV reporting will be important.
  • This is both a strategic and tactical role.  This SM/AD will perform detailed reviews of case reporting and safety databases, while also providing thoughtful analyses of trends, establishing SOPs, etc.  Seek candidate who is a hands-on doer as well as a strategic thinker.
  • This company is in high growth mode.  Policies, practices and procedures are being developed, enhanced and reconsidered.  Seek process improvement-oriented leader who brings ideas, ingenuity and initiative to these efforts.

Selected Duties:

  • Support the Executive Director, Drug Safety & Pharmacovigilance in the management, maintenance, and continuous improvement of Pharmacovigilance operational activities
  • Manage external PV vendor(s) including quality oversight of case reporting, safety data exchange agreements, contract/budget management, etc.
  • Ensure that the PV function (in house and outsourced), is operationalized according to the highest industry standards, as well as in compliance with company policies and SOPs
  • Drive continuous process improvement of internal and jointly owned (with PV vendor) PV SOPs, standards, metrics, templates, and procedural documents
  • Ensure compliant & timely coordination of safety related activities between company, business partners, and PV vendor
  • Ensure quality monitoring of case processing and aggregate reports
  • Partner with Executive Director and Quality department on audit and inspection readiness
  • Monitor, measure, and track compliance and partner with Quality department to ensure implementation of effective corrective and preventative actions as needed
  • Support regulatory inspections, internal and business partner audits, training, and other projects

This position requires a person with a “can-do” attitude, who thinks strategically but is hands-on, detail-oriented, and completely committed to achieving the precision, quality, and accuracy necessary in Pharmacovigilance and Drug Safety.

Requirements include a Bachelor’s degree as well as 5+ years in Drug Safety operations, including substantial experience with marketed drugs.  Bkgd leading Drug Safety/PV within an emerging pharma is strongly preferred.

Other priorities include:

  • Substantial experience driving the work done by 3rd party vendors including managing related contracts
  • Extensive experience in core Drug Safety functions including case processing, compliance monitoring, quality monitoring, PV systems, audit/inspection readiness, KPIs/metrics, etc.
  • Strong understanding of drug development and PV regulatory requirements including safety reporting in post-marketing surveillance, clinical trials, case processing, reporting to FDA, EMA, etc.
  • Experience in working with safety databases (Argus) and other safety technology solutions.
  • Experience with establishing and tracking performance metrics, compliance, and quality monitoring.
  • Superb project management and process management skills
  • Ability to lead and influence cross-functional teams to achieve shared goals
  • Track record of longevity, impact and achievement

Finally, we seek a candidate who will thrive in an emerging business setting; someone who is excited to be part of a growing organization, will be flexible, adaptable and versatile and will bring the insights, ideas and initiative to help build a Best Practices team.

 This is an immediate need.  Please forward Word resume for prompt consideration.