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
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.
- 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.
- 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.