Manager - Global Pharmacovigilance

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.

This is a hybrid position requiring at least two days a week onsite at our office in Warren, NJ.

• 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.

• 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

We’re built on a simple belief: people living with rare diseases deserve more. Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long-term commitment, and…