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