Pharmacovigilance Manager at Pharming Group
Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is small (approx. 180 employees, based internationally) and growing quickly. As a result of this growth, we are looking for a:
Overall purpose of the job:
As a Pharmacovigilance Manager you are responsible for safety evaluation of Pharming product(s), including case process, signal detection and workups; proactive management of potential safety issues, overseeing the processing of (S)AE reporting, management of the processes for all SAE data and responses to regulatory agency safety enquiries.
Main duties and responsibilities:
- Collects and collate reported (S)AEs associated with the use of Pharming’s product(s) both in development and authorized,
- Checks reported information on completeness and consistency of data,
- Performs case assessment including determining seriousness, reportability etc.,
- Enters all relevant data in the Pharmacovigilance database including editing narratives,
- Prepares follow-up queries and communicate with the reporters in order to obtain follow-up information for the (S)AEs received,
- Responsible for expedited submission of individual case safety reports to Competent Authorities, i.e., EMA, Ethics Committees and other parties as applicable within the timelines specified per applicable legal requirement (e.g., 7/15 day reporting timeline),
- Answers and/or supports/contributes to the answering of questions from Competent Authorities, i.e., EMA or Health Care Professionals,
- Performs reconciliation of safety information arising from clinical trials with Data management
- Co-ordinates the PV Signal Detection Meetings in discussions relating to all aspects of safety relating to the company’s products,
- 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 of partner/distributors with local pharmacovigilance agreements by conducting routine and for cause GPvP audits,
- Performs other related duties as assigned or requested by the Senior PV director,
- Fill in for other PV staff (e.g., PV manager in Leiden) as required.
Bachelor of Science degree in life sciences subject, pharmacy or nursing, ideally with MSc or PhD.
- 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,
- Sufficient level of management and training expertise,
- Proven periodic reports writing experience.
Are you interested? Please e-mail your CV and letter of motivation to: firstname.lastname@example.org.