Global Pharmacovigilance Lead

Pharming Group; Northern (KY); Hybrid; USD 105,000 - 135,000; Full time

Benefits offered by this job

Hybrid work schedule

Annual target bonus

Long-term incentive program

401(k) plan with company match

PTO

13 Company Holidays

Medical, dental, and vision

Flexible spending accounts

Life insurance

Disability plans

Pet insurance

Health and wellness program

Phone stipend

Job summary

Pharming Healthcare, Inc. is seeking a Pharmacovigilance professional to oversee safety case processing, data entry, and timely reporting to FDA/EMA while ensuring global PV compliance. The role involves on-site work twice a week at our Warren, NJ office in a hybrid setup.

You will collect and review (S)AEs, perform case assessments, prepare submissions, and develop data outputs for stakeholders. A strong PV background and ARGUS experience are essential.

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.
• Commitment and alignment to Pharming’s mission and values

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

Pharmacovigilance

Case processing

Data entry

Safety database

FDA/EMA reporting

Education

BS in life sciences/pharmacy/nursing

Masters or PharmD preferred

Tools

ARGUS

Job description

Pharming Healthcare, Inc. is seeking a Pharmacovigilance professional to oversee safety case processing, data entry, and timely reporting to FDA/EMA while ensuring global PV compliance. The role involves on-site work twice a week at our Warren, NJ office in a hybrid setup.

You will collect and review (S)AEs, perform case assessments, prepare submissions, and develop data outputs for stakeholders. A strong PV background and ARGUS experience are essential.