Senior Manager, Drug Safety & PV, Quality Standards & Training

Job Description

Job Summary:

• In support of 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.

Duties and 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 & Pharmacovigilance (DSP) training administration and management.
• Liaises with company 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.
• Evaluates 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 by 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 company PV system as required by regulations (e.g., EU PV Masterfile).
• Assists in preparation and execution of the DSP Business Continuity Plan in collaboration with other stakeholders (e.g., IT, Regulatory).
• Other duties as assigned.

Education & Experience:

• Bachelor’s degree in Life Science or related field.
• Client in 5 years of progressively responsible experience within the pharmaceutical or biotech industry, including:
• 3 years in Pharmacovigilance
• 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.

Knowledge, Skills, and Abilities:

• 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
• 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.

Physical Requirements:

• While performing the duties of this job, the employee is regularly required to:
• Stand
• Walk
• Sit
• Use hands to finger, handle, or feel
• Reach with hands and arms
• Climb or balance
• Stoop, kneel, crouch
• See, talk, or hear in a standard office environment and independently from remote locations.
• Employee must occasionally lift and/or move up to 15 pounds.
• Ability to travel independently overnight and work after hours if required by travel schedule or business issues.