Manager, Pharmacovigilance Operations

The Steely Group; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

The Steely Group is seeking a Consultant Manager, Pharmacovigilance to oversee PV operations, case management, and vendor oversight for clinical trials and post-marketing safety activities. You will collaborate with PV and cross-functional teams to ensure quality, compliance, and timely safety reporting.

You will lead safety operations, vendor relationships, and development of PV policies, while supporting audits and regulatory inquiries.

Qualifications

• Bachelor’s or advanced degree in life sciences or healthcare.
• Minimum 5–7 years of direct pharmacovigilance experience.
• Experience with safety databases (ARGUS, ARISg, or other safety database applications), EDC systems, and electronic document management systems.
• Knowledge of GCPs, ICH guidelines and FDA/EMA/international regulations.
• Working knowledge of MedDRA and WHO Drug dictionaries.
• Experience with onboarding, overseeing and managing safety vendors.
• ICSR submission experience is highly preferred.
• Strong interpersonal and communication skills; proactive approach.
• Detail-oriented with good organizational, prioritization, and time management skills.
• Proficient in Word, Excel, and PowerPoint; familiarity with safety database configuration/validation is desirable.

Responsibilities

• Provide oversight of PV operational and case management activities for safety reporting.
• Escalate issues to management as needed.
• Lead PV vendor management oversight activities including day-to-day oversight and vendor performance review.
• Generate performance and compliance metrics for PV vendors and monitor trends.
• Lead safety operations support on assigned studies.
• Contribute to safety documentation such as Safety Management Plans and reporting forms.
• Support Regulatory Authority inspections and audits as subject matter expert.
• Collaborate to develop processes and training for Patient Support Programs and Market Research.

Skills

Pharmacovigilance

Vendor management

Team collaboration

GCP/ICH compliance

MedDRA/WHO dictionaries

ICSR submission

Safety databases (ARGUS/ARISg)

EDC systems

Electronic document management

MS Office

Regulatory knowledge

Education

Bachelor's or advanced degree in life sciences or healthcare

MD/PhD/PharmD (optional)

Tools

ARGUS/ARISg

EDC systems

Electronic document management

MS Office

Job description

The Consultant Manager, Pharmacovigilance (PV) operations collaborates very closely with the PV team and the cross functional teams to manage clinical trials and post-marketing case management and vendor oversight activities for contracted PV vendor(s).

The position requires an experienced and confident manager who can collaborate with multiple stakeholders internally and with the vendor(s) to ensure compliance and high-quality standards. The individual in this position must be able to manage multiple tasks at once and prioritize completing requests or projects.

This position will report to the Senior Manager/Manager, Pharmacovigilance.

Key Responsibilities:

• Provide oversight of the PV operational and case management activities for safety reporting including the collection, processing, and reporting/submission of safety information for all products (investigational and commercial) including the review and monitoring of case quality and compliance through various monitoring reports and other oversight activities
• Escalate issues to management as needed
• Lead PV vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality
• Generate performance and compliance metrics for the PV vendor and monitor for trends or possible improvements
• Lead and provide safety operations support on assigned studies
• Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties
• Support SAE reconciliation activities on assigned clinical studies
• Collaborate with study team members to develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions
• Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits as subject matter expert on Pharmacovigilance operations
• Contribute to safety requests from Regulatory Authorities
• Participate in the development and maintenance of PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
• Review new or updated PV regulations for modifications to internal procedures or changes to the agreements with vendors or partners
• Collaborate with Medical Affairs, Commercial, or Marketing to develop processes, forms, and/or training to support Patient Support Programs, Market Research, and Investigator Initiated Studies
• Other responsibilities as assigned

Required Qualifications:

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
• Minimum of 5-7 years of direct pharmacovigilance experience
• Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems.
• Knowledge of GCPs, ICH guidelines and FDA, EMA, and other international regulations and guidelines
• Working knowledge of MedDRA and WHO Drug dictionaries
• Experience with onboarding, overseeing and managing safety vendors
• ICSR submission experience is highly preferred
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Proficient in standard computer software (Word, Excel and Power point presentations)
• Previous experience and formal training with safety database programs including configuration and validation activities is desired