Global Pharmacovigilance Manager: Safety & Compliance Lead

Remote Co.; Kentucky; Hybrid; USD 105,000 - 135,000; Full time

Benefits offered by this job

Hybrid work schedule

Annual bonus

401(k) plan with company match

PTO

Health, dental, vision

Job summary

Pharming Healthcare, Inc. seeks a Manager - Global Pharmacovigilance to lead safety evaluation of products, oversee case processing, and ensure timely reports to regulators. This hybrid role requires on-site presence in Warren, NJ twice a week and a strong command of PV regulations, GCP/ICH, and data management.

You will coordinate with authorities (FDA/EMA), manage data output, and support business development on safety matters. A BS in life sciences and at least three years in PV are required.

Qualifications

• BS Degree in relatable subjects i.e. life sciences, pharmacy or nursing; Masters or PharmD degree preferred
• At least three years of industry experience in pharmacovigilance and drug safety
• Extensive knowledge of pharmacovigilance especially case processing and drug safety evaluation
• Extensive knowledge of safety database (ARGUS strongly preferred)
• In depth understanding of good pharmacovigilance practices and current drug safety regulations
• Good knowledge of GCP/ICH guidelines.

Responsibilities

• Collecting and collating reported (S)AEs associated with the use of Pharming’s product(s) both in development and post-authorization.
• Checking reported information on completeness and consistency of data.
• Performing case assessment including determining seriousness, reportability etc.
• Entering all relevant data in the Pharmacovigilance database including editing narratives.
• Preparing follow-up queries and communicating with the reporters to obtain follow-up information for the (S)AEs received.
• Responsible for expedited submission of individual case safety reports to competent authorities, i.e., FDA, EMA, Ethics Committees, partners and other parties as applicable within timelines specified per applicable legal requirement (e.g., 7/15 day reporting timeline).
• Developing data output: database queries and data visualization in support of internal stakeholder requests (aggregate reports, signaling outputs, reconciliation, etc)
• Answering and/or supporting/contributing to the answering of questions from competent authorities.
• Performing reconciliation of safety information arising from clinical trials with data management.
• Alerting company personnel of any possible adverse changes to the risk-benefit profile of company products and providing relevant information as required to make an assessment.
• Maintaining a current awareness of legislation and practices relating to PV and ensuring the company complies with changing global requirements through updating procedures, practices and database configuration as appropriate.
• Designing and implementing procedures to ensure the smooth running of the Pharmacovigilance Department.
• Ensuring compliance of partner/distributors with local pharmacovigilance agreements by supporting routine and for cause GvP audits.
• Overseeing the database set-up of all new studies including the preparation of study specific SAE processing documents (e.g., Safety Reporting Plan).
• Assisting Business Development in all safety related issues required for the preparation of proposals/contracts for partners/distributors.
• Performing other related duties as assigned or requested by the PV Senior Manager and the VP, GPV.
• Providing out of office support for other PV staff, as required.
• Other duties as assigned.

Skills

PV experience

Case processing

Regulatory liaison

Data retrieval

GCP/ICH knowledge

Education

BS in life sciences/pharmacy/nursing

Masters or PharmD preferred

Tools

ARGUS PV Database

Job description

Pharming Healthcare, Inc. seeks a Manager - Global Pharmacovigilance to lead safety evaluation of products, oversee case processing, and ensure timely reports to regulators. This hybrid role requires on-site presence in Warren, NJ twice a week and a strong command of PV regulations, GCP/ICH, and data management.

You will coordinate with authorities (FDA/EMA), manage data output, and support business development on safety matters. A BS in life sciences and at least three years in PV are required.