Senior Manager – Drug Safety & PV Quality Standards & Training
| Company | Acadia Pharmaceuticals |
|---|---|
| Location | Princeton, NJ, USA, San Diego, CA, USA |
| Salary | $1 – $2 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in Life Science or related field
- Targeting 7 years of progressively responsible experience within the pharmaceutical or biotech industry, including 3 years in Pharmacovigilance with prior oversight of PV compliance, quality and training
- Experience with industry interpretation of regulatory expectations and with pharmacovigilance inspections by major global Health Authorities
- Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, developing and maintaining SOPs and training programs, and PV systems/databases
- Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance, including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, and reporting to Health Authorities worldwide
- Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice, and make sound decisions
- Ability to drive standards and change across functional areas and sites
- Strong attention to detail in establishing priorities, scheduling, and meeting deadlines
- Ability to work independently, take initiative, and complete tasks to deadlines
- Excellent interpersonal, communication, analytical, and organizational skills
- Demonstrated ability to motivate, lead, and train others
- Willingness and ability to travel as needed
Responsibilities
- Supports all compliant PV system-related activities by ensuring appropriate processes are in place for the collection, collation, evaluation, and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements
- Assists with implementing drug safety standards across other areas that input to the PV system, such as clinical research, medical affairs, commercial, etc.
- Contributes to preparing and presenting Key Performance Indicator (KPI) reports
- Supports Drug Safety and PV (DSP) Training administration and management
- Liaises with Acadia stakeholders to ensure all vendors are properly trained and that training is documented
- Maintains all required SOP training matrices for all DSP roles
- Supports PV inspections and audits; collaborates cross-functionally in preparation of responses to findings
- Leads monitoring and management of DSP quality events/deviations investigations
- Evaluate adequacy and completeness of CAPAs and Effectiveness Checks (ECs) originated from audits, and/or quality events/deviations
- Supports Quality Management Reviews for all DSP deliverables
- Supports DSP procedural development and maintenance; collaborates with Subject Matter Experts (SMEs); liaises with other departments on cross-functional procedures that involve DSP
- Supports Regulatory Intelligence for DSP
- Contributes to documents describing the Acadia PV system as required by regulations (e.g., EU PV Masterfile)
- Assist in preparing and executing the DSP Business Continuity Plan in collaboration with other stakeholders (e.g., IT, Regulatory)
- Other duties as assigned
Preferred Qualifications
- Experience with Veeva and ARGUS is preferred