Director Pharmacovigilance - Leiden, Nederland - Pharming Group

Pharming Group

Geverifieerd bedrijf

Leiden, Nederland

4 weken geleden

Geplaatst door:

Daan Van den Berg

werver van beBee

Beschrijving

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 gene therapies 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.

The role:

Responsible for safety evaluation of Pharming product(s), including benefit/ risk assessment of medicinal products, case processing, signal detection and workups; proactive management of potential safety issues, overseeing the processing of (S)AE reporting, management of the processes for all (S)AE data and responses to safety requests from Competent Authorities worldwide.

Support the Vice President PV/EU QPPV.

Areas of responsibility:

Supports the Vice President PV/EU QPPV to ensure the smooth running of the Global Pharmacovigilance Department
Responsible for benefitrisk profile assessment of Pharming's products
Alerts company personnel of any possible adverse changes to the riskbenefit profile of company products and to provide relevant information as required to make an assessment.
Responsible for signal detection activities and signal management.
Responsible for RMP update
Takes the lead of CCDS/CCDI update, and collaborates with Global Regulatory Affairs team in discussion, preparation, and compilation, quality checking of labeling update.
Acts as local PV contact person wherever needed
Collects and collates reported (S)AEs associated with the use of Pharming's product(s) both in development and authorized
Oversees the case processing in safety database
Conduct medical review by making medical assessment on individual case report including seriousness, causality, reportability etc., prepares the followup queries as appropriate
Answers and/or supports/contributes to the response of questions from Competent Authorities, e.g., EMA, MHRA, and FDA
Participates in audits or inspections whenever needed
Maintains a current awareness of legislation and practices relating to PV and ensures the company complies with changing requirements through updating procedures and practices as appropriate.
Ensures compliance with current legal obligations and guidelines and other industry standards relating to PV
Supports on aggregate reports, e.g., PSUR (PBRER) and DSUR, from medical perspective
Upon request oversees the setup of all new studies including the preparation of study specific SAE processing documents and Safety Management Team (SMT).
Performs other related duties as assigned or requested by the Vice President PV/EU QPPV

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

A highly competitive salary
8.33% holiday allowance (for NL)
A minimum of 30 vacation days
An excellent pension plan
Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs.

Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all "Pharmers".

Also important We truly value a healthy life-work balance with a lot of flexibility.

Does this sound like you and do you want to join our team? Then we'd love to hear from you

We're an equal opportunity employer.

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.