Manager - Global Pharmacovigilance

Pharming Group N.V.•Warren Township, NJ

6d•$105,000 - $135,000•Hybrid

About The Position

This position provides safety evaluation of Pharming product(s), including case processing, signal detection and workups. Our goal for this position is to proactively manage potential safety issues, oversee the processing of (S)AE reporting, perform data retrieval and respond to regulatory agency safety enquiries. Successful execution will involve in depth knowledge of current drug safety regulations and a sufficient level of case management expertise.

Requirements

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.

Benefits

Flexible hybrid work schedule to promote a healthy work-life balance
Competitive compensation package including annual target bonus
Long-term incentive program
401(k) plan with company match
Paid Time Off (PTO)
13 Company Holidays per year
Excellent benefit plans including medical, dental, and vision
Flexible spending accounts
Company-provided life insurance, short-term disability, and long-term disability plans
Optional accident, hospital indemnity, critical illness, and pet insurance plans
Tuition reimbursement program
Health and wellness program
Choice of company provided mobile phone or cell phone stipend