Director Pharmacovigilance at Pharming Group

Overall purpose of the job:

Responsible for safety evaluation of Pharming product(s) including signal detection, proactive management of potential safety issues, and benefit/risk assessment of medicinal products.

The Pharmacovigilance group is a growing and enthusiastic team, full of energy and 
commitment.
 

 

Main duties and responsibilities:

  • Supports EU Qualified Person Responsible For Pharmacovigilance (QPPV) to ensure the smooth running of the Pharmacovigilance Department.
  • Acts as Deputy QPPV and back-up of EU QPPV if needed.
  • Collects and collates reported Serious Adverse Events associated with the use of Pharming’s product(s) both in development and authorized. 
  • Oversees the case processing in safety database.
  • Conducts medical review by making medical assessment on individual case report including seriousness, causality, reportability etc., prepares the follow-up queries as appropriate.
  • Answers and/or supports/contributes to the response of questions from Competent Authorities, i.e., EMA, FDA.
  • Takes the lead of signal detection activities; hosts the pharmacovigilance (PV) signal detection meetings in discussions relating to all aspects of drug safety associated with the company’s products. 
  • Responsible for benefit-risk profile assessment of company products. 
  • Takes the lead of Risk Management Plan update. 
  • Upon request, ensures compilation, review and submission of periodic reports for company products and identifies any significant differences between the Core Safety Information and the approved local labeling. 
  • Supports on periodic reports, e.g., safety update reports from medical perspective. 
  • Supports on PV training for company or non-company personnel. 
  • Supports on reconciliation of safety information arising from clinical trials with Data management as appropriate.
  • 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. 
  • Upon request, collaborates with Regulatory Affairs team in discussion, preparation, and compilation, quality checking of labeling update, e.g., EU Summary of Product Characteristics. 
  • Ensures compliance with current legal obligations and guidelines and other industry standards (Good Pharmacovigilance Practice). 
  • Upon request oversees the set-up of all new studies including the preparation of study specific SAE processing documents (e.g., Safety Reporting Plan). 
  • Performs other related duties as assigned or requested by the Senior PV director/EU QPPV.
     


Qualifications:

  • Master or PhD degree in medicine, life sciences or pharmacy.
  • Minimum 6 years of industry experience in pharmacovigilance and drug safety. 
  • Experienced in training and management of a pharmacovigilance group.
  • Experienced with internal and external audits is a plus.
  • Extensive knowledge of pharmacovigilance especially case process, drug safety evaluation and signal detection.
  • In depth understanding of good pharmacovigilance practices and current drug safety regulations. 
  • Good knowledge of GCP/ICH guidelines.
  • A sufficient level of management and training expertise. 
  • Proven periodic reports and Risk Management Plan writing experience.


Skills:

  • Fluent in Dutch and English, both in word and writing.
  • Effective communication skills.
  • Able to work under high pressure.
  • Coaching and coordinating skills.
  • Decisive and pro-active.

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