Job title: Sr Manager, Drug Safety & PV, Quality Standards & Training
Duration: 11+ months (Possible Extension)
Work Model: remote (Eastern time)
 
Duties:

• In support of the company and fulfillment of global legislation and regulations, the Senior Manager will be responsible for the global oversight for quality and compliance of the Pharmacovigilance (PV) and risk management activities. This is accomplished through setting and articulating the vision for the PV system, including but not limited to development and execution of global processes, standards, training programs and compliance monitoring.

 
Primary 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 implementation of drug safety standards across other areas that input to the PV system such as clinical research, medical affairs, commercial, etc.
• Contributes to the preparation and presentation of Key Performance Indicator (KPI) reports.
• Supports Drug Safety & PV (DSP) Training administration and management. Liaise with stakeholders to ensure all vendors are also properly trained and 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; collaborating 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 PV system as required by regulations (e.g., EU PV Masterfile).
• Assist in preparation and execution of DSP Business Continuity Plan in collaboration with other stakeholders (e.g., IT, Regulatory).
• Other duties as assigned.

 
Skills:

• Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, development and maintenance of SOPs and training programs, and PV systems/databases.
• Experience with Veeva and ARGUS is preferred.
• 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.

 
Scope

• Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Establishes strategic plans for designated function(s).
• Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.
• Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the Company.

 
Education:

• Bachelor’s degree in Life Science or related field.
• Targeting 5 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.
• Must have experience with industry interpretation of regulatory expectations and with pharmacovigilance
• inspections by major global Health Authorities.
• An equivalent combination of relevant education and experience may be considered.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $70.00/hr - $77.00/hr.