Manager, Pharmacovigilance Operations

Arena Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 51 days ago

The opportunity

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

We are seeking a Manager of Pharmacovigilance (PV) Operations who will assist the Director of PV Operations in the safety operational oversight of CROs and vendors and who will contribute to managing other daily activities for global SAE case processing and submissions. 

What you’ll dive into

  • Assisting with oversight and management of safety vendor to ensure timely SAE case entry, processing, notification to business partners, and expedited report submission and tracking
  • Monitoring different project related safety issues, facilitates group meetings, and follows up on action items/initiatives to ensure safety actions are addressed
  • Assisting in the development and review of Safety Management Plan (SMP), protocols and any other safety related documents
  • Supporting the management of communications and timelines with applicable partner companies and respective CROs regarding the intake, case processing, medical review and global submission of ICSRs, as well as global safety aggregate reports (e.g.; DSURs, 6M LL, PSURs/PBRERs)
  • Assisting with the establishment and ongoing review of key performance indicators
  • Collaborating with cross-functional stakeholders (e.g., study/safety CROs, other departments) on any late report corrective and preventive action (CAPA) plans in order to address delays in reporting on a timely manner
  • Liaising with various external and internal groups to maintain a high level of quality and consistency across functional teams on best practices and industry standards
  • Participating in training the investigators, CRAs, CROs, and company staff on SAE reporting obligations; participation in study kick-off meetings
  • Acting as an ad hoc Safety Operations representative to Clinical Study Teams with respect to safety data/process updates
  • Collaborating with the PV & Drug Safety team in the development of Drug Safety SOPs
  • Supporting PV on GxP audits (internal and external) and inspections
  • Providing back-up support to the Director of PV Operations as needed
  • Maintaining currency with evolving international guidance and regulations for global safety reporting, safety surveillance and risk management in both a clinical and eventual post-marketed setting (FDA, EMA CFDA/SFDA, and other Asia/Pacific territories) 
  • Mentoring, training, and supervising members of the PV staff (e.g., Drug Safety Specialists/Associates)

What we expect

  • A Bachelor’s degree (health care professional preferred, e.g. nurse, pharmacist and etc.), with a minimum of 5 years of Drug Safety experience
  • Relevant experience in global Drug Safety case processing, with preference for clinical trial safety experience
  • Demonstrated proficiency with Argus safety database, MedDRA coding, Microsoft Office programs (Word, Excel, PowerPoint, Outlook)
  • Proven ability to manage multiple priorities
  • Competencies in drug safety regulations and guidance (FDA, ICH, EU GVP)
  • Familiarity with the content of standard pharmacovigilance documents such as SOPs, guidelines, safety plans
  • Ability to independently identify problems and effectively offer solutions
  • Excellent written/oral communication, personal organizational skills and resourcefulness
  • Ability to work collaboratively as part of a team in a fast-paced challenging environment
  • Attention to detail, accuracy
  • Expert time management skills, with the ability to prioritize workload
  • Self-motivated and capable to work independently

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations