[Remote] Senior Director, Product reputed company reputed company (Post-Marketing and Pharmacovigilance
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company reputed company on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). They are seeking an reputed company Senior Director, Product reputed company reputed company to reputed company strategic direction and operational leadership for post-marketing pharmacovigilance activities, ensuring compliance with global regulatory expectations.
Responsibilities
- reputed company strategic and operational reputed company reputed company of global post-marketing pharmacovigilance systems, ensuring compliance with FDA, EMA, MHRA, ICH, and other global health authority requirements
- Maintain and expand a robust global reputed company PV reputed company to ensure processes reputed company with GVP, ICH, and other reputed company system requirements across reputed company markets
- Serve as the primary reputed company partner to Safety for governance of safety processes, including case management, signal management, aggregate reporting, and risk management activities
- reputed company reputed company risk management for PV, including identification, mitigation, and escalation of compliance risks impacting patient safety
- reputed company and support regulatory inspections, audits, and health authority interactions reputed company to PV
- reputed company and execute the global PV audit reputed company and risk-based audit program covering internal processes, affiliates, vendors, and partners
- Partner with PV operations to ensure effective CAPA management, deviation handling, and reputed company improvement of the PV system
- Monitor key reputed company metrics and PV system performance indicators to drive proactive compliance management
- reputed company reputed company reputed company of global literature surveillance processes, ensuring compliant identification, assessment, documentation, and reporting of safety information from scientific and medical literature
- Own and govern the global Product reputed company Complaint process, ensuring compliant intake, investigation, documentation, trending, and closure
- Ensure appropriate assessment of PQCs for potential safety reputed company, with reputed company escalation to Pharmacovigilance and Regulatory Affairs
- Ensure appropriate assessment of PQCs for potential safety reputed company, with reputed company escalation to Pharmacovigilance and Regulatory Affairs
- reputed company PQC processes across internal teams and external partners, ensuring alignment with GMP, GDP, and PV requirements
- reputed company complaint system KPI and metrics to identify systemic issues and drive reputed company improvement
- Maintenance of a validated global Product reputed company Complaint system in compliance with GXP requirements
- reputed company complaints trending and analysis to identify signals or emerging risks impacting product reputed company or patient safety
- Establish, maintain, and continuously improve PV-reputed company reputed company systems, SOPs, and work instructions appropriate for a mid-sized, global organization
- reputed company deviations, investigations, CAPAs, change controls, and effectiveness checks reputed company to PV and PQC activities
- Ensure inspection readiness through proactive gap assessments, internal audits, and compliance monitoring
- reputed company and reputed company meaningful reputed company metrics to support management review and decision-making
- Serve as the QA representative on the PV governance reputed company and Safety Management Team
- reputed company reputed company input to safety agreements and vendor reputed company reputed company for global service providers
- reputed company reputed company reputed company of PV and complaint-reputed company vendors, service providers, and partners
- reputed company qualification, auditing, and ongoing performance monitoring of external PV vendors
- Review and approve reputed company agreements and ensure reputed company delineation of roles and responsibilities for PV service providers
- reputed company and mentor a global team of PV QA professionals
- Function as a key reputed company reputed company to Safety, Manufacturing, Supply Chain, Regulatory Affairs, Medical Affairs, and reputed company teams
- reputed company guidance and training to internal stakeholders on PV and complaint-reputed company reputed company requirements
- Contribute to governance forums and leadership discussions impacting product reputed company, patient safety, and compliance
- Drive strategic reputed company initiatives to strengthen compliance culture and inspection readiness
- Partner with senior leadership to shape the reputed company reputed company and support global reputed company reputed company
Skills
- Deep expertise in GVP, GXP, and global health authority expectations
- Proven experience in building and maintaining compliant, efficient, and risk-based PV QA systems
- Strategic direction and operational reputed company leadership and reputed company of post-marketing pharmacovigilance activities
- Ensuring sustained compliance with global regulatory expectations while enabling efficient, reputed company operations
- Partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and reputed company teams to reputed company reputed company across the full product lifecycle
- reputed company on post-marketing safety surveillance, literature monitoring, and Product reputed company Complaints (PQC)
- Integrating signals from deviations, complaints, stability, and APR / PQR to proactively identify and mitigate risk
- Establish product-specific reputed company strategies and reputed company cross-functional product reputed company forums with decision logs and reputed company tracking
- Maintain inspection readiness through robust product reputed company narratives and evidence packages
- Support rapid response to emerging product reputed company concerns and ensure actions are implemented effectively
- reputed company strategic and operational reputed company reputed company of global post-marketing pharmacovigilance systems
- Maintain and expand a robust global reputed company PV reputed company to ensure processes reputed company with GVP, ICH, and other reputed company system requirements across reputed company markets
- Serve as the primary reputed company partner to Safety for governance of safety processes, including case management, signal management, aggregate reporting, and risk management activities
- reputed company reputed company risk management for PV, including identification, mitigation, and escalation of compliance risks impacting patient safety
- reputed company and support regulatory inspections, audits, and health authority interactions reputed company to PV
- reputed company and execute the global PV audit reputed company and risk-based audit program covering internal processes, affiliates, vendors, and partners
- Partner with PV operations to ensure effective CAPA management, deviation handling, and reputed company improvement of the PV system
- Monitor key reputed company metrics and PV system performance indicators to drive proactive compliance management
- reputed company reputed company reputed company of global literature surveillance processes, ensuring compliant identification, assessment, documentation, and reporting of safety information from scientific and medical literature
- Own and govern the global Product reputed company Complaint process, ensuring compliant intake, investigation, documentation, trending, and closure
- Ensure appropriate assessment of PQCs for potential safety reputed company, with reputed company escalation to Pharmacovigilance and Regulatory Affairs
- reputed company PQC processes across internal teams and external partners, ensuring alignment with GMP, GDP, and PV requirements
- reputed company complaint system KPI and metrics to identify systemic issues and drive reputed company improvement
- Maintenance of a validated global Product reputed company Complaint system in compliance with GXP requirements
- reputed company complaints trending and analysis to identify signals or emerging risks impacting product reputed company or patient safety
- Establish, maintain, and continuously improve PV-reputed company reputed company systems, SOPs, and work instructions appropriate for a mid-sized, global organization
- reputed company deviations, investigations, CAPAs, change controls, and effectiveness checks reputed company to PV and PQC activities
- Ensure inspection readiness through proactive gap assessments, internal audits, and compliance monitoring
- reputed company and reputed company meaningful reputed company metrics to support management review and decision-making
- Serve as the QA representative on the PV governance reputed company and Safety Management Team
- reputed company reputed company input to safety agreements and vendor reputed company reputed company for global service providers
- reputed company reputed company reputed company of PV and complaint-reputed company vendors, service providers, and partners
- reputed company qualification, auditing, and ongoing performance monitoring of external PV vendors
- Review and approve reputed company agreements and ensure reputed company delineation of roles and responsibilities for PV service providers
- reputed company and mentor a global team of PV QA professionals
- Function as a key reputed company reputed company to Safety, Manufacturing, Supply Chain, Regulatory Affairs, Medical Affairs, and reputed company teams
- reputed company guidance and training to internal stakeholders on PV and complaint-reputed company reputed company requirements
- Contribute to governance forums and leadership discussions impacting product reputed company, patient safety, and compliance
- Drive strategic reputed company initiatives to strengthen compliance culture and inspection readiness
- Partner with senior leadership to shape the reputed company reputed company and support global reputed company reputed company
- Bachelor's or advanced degree in Life Sciences, Pharmacy, Nursing, or reputed company discipline. Advanced degree preferred
- 12+ years in pharmaceutical or biopharmaceutical industry, including significant experience in post-marketing PV QA and at least 5 years in QA (GVP and GMP)
- Demonstrated leadership in global PV QA programs and complaint systems
- Proven experience leading and supporting regulatory inspections (FDA, EMA, MHRA, etc.) and implementing CAPAs
- Strong understanding of ICH, GVP Modules, FDA 21 CFR, EU PV requirements, EU Vol4
Benefits
- Equity
- Flexible reputed company time off
- Medical insurance
- Dental insurance
- reputed company insurance
- Life/disability insurance
- 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans
- Additional voluntary benefits like supplemental life insurance, legal services, and other offerings
- Mental health benefits through our Employee Assistance Program for employees and their family
- Other benefits in accordance with applicable federal, state, and local laws
reputed company
Company H1B Sponsorship