Manager, Pharmacovigilance

About Pharming

Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases.  Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and proteins that are in early to late-stage development.  Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture

Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged.  Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Overview

Pharming is seeking to hire a Manager, Pharmacovigilance to provide 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 management expertise. This role reports directly to the Senior Manager - Global Pharmacovigilance.

Key Responsibilities

The Manager, Pharmacovigilance will be responsible for a wide variety of matters in support of Pharming’s growth as we increase the number of both pipeline and marketed products. 

Core functions include:

• 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.
• Providing company or non-company personnel with PV training (e.g., non-PV staff within Pharming., CRAs, investigators, sales representatives, customer service, if needed).
• 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.
• Under oversight of Medical-Safety Physician, co-ordinates the PV Signal Detection Meetings.
• 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.
• This is a hybrid role; 2 to 3 days at Warren, NJ office.

Minimum Qualifications 

• BS Degree in relatable subjects i.e. life sciences, pharmacy or nursing. Masters or PharmD degree preferred.
  • BS Degree : Minimum 5+ years OR Masters/PharmD Degree: Minimum 3+years of industry experience in pharmacovigilance and drug safety.

Preferred Qualifications

• Sufficient level of management and training expertise.
• Proven periodic reports writing experience.
• Extensive knowledge of pharmacovigilance especially case process, drug safety evaluation and signal detection.
• Extensive knowledge of safety database (ARGUS)
• In depth understanding of good pharmacovigilance practices and current drug safety regulations
• Good knowledge of GCP/ICH guidelines.

Salary Range

Pharming takes into consideration a combination of candidate’s work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

The base salary range for this job is from $107,000 to $117,000 per year.