Title:

Physician - Global Patient Safety

Company:

Ipsen Biopharm Ltd

Job Description:

The role will support the Global Patient Safety Therapeutic Area Leaders with scientific analysis, data reviews, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents.

You will be required to;

§ Provide scientific review and interpretation of safety data for the preparation of

aggregate reports such as Development Safety Reports (DSURs), Periodic Safety Update

Reports (PSURs), etc; this includes the management and monitoring of vendors used to

author such documents

§ Provide scientific expertise during signal detection activities, signal evaluation and risk

assessment, and manage the process for the development and management of Risk

Management Plans

§ Work cross-functionally to ensure that Clinical, Franchise and Regulatory objectives are

met by reports being submitted according to international regulatory requirements and

Company objectives and timelines

§ Provide scientific expertise to the preparation of responses to internal and external

questions relating to the safety of products on the market or during clinical trials; this

includes the management and monitoring of external vendors used to author such

documents

 Deliver efficient and timely review of clinical trial documentation (protocols, study

reports, monthly reports of serious adverse events, etc).

 Provide requisite regular reports of safety data, including appropriate scientific data

analysis, to support the MDD and the GPS TA Leader in efficient medical monitoring

 Assist in the implementation of Data Safety Monitoring Committees, ensuring the

provision of accurate high quality pharmacoviglance data for review

 Review clinical trials safety data throughout the clinical development programme, to

ensure that any medical issues are raised with the GPS TA Leader, and that data meet

the quality standards for regulatory requirements

 Provide, or ensure the provision of, an overview of pharmacovigilance definitions and

Standard Operating Procedures to study investigators and site monitors at study set-

up, and whenever necessary during the running of the trial, in order to ensure that

serious adverse events (SAEs) are reported to the Company in a timely and accurate

manner and that regulatory safety requirements are understood and met

 Liaise with Global Drug Development CROs to ensure that SAE data within the clinical

clinical trials

§ Liaise with GDD CRO staff to ensure that they understand their responsibilities for

processing safety data as described in the RFP and contract, including contributions to

safety data handling plans and other similar documentation, and that SAEs are

reported to the Company according to the required timelines

§ Ensure the timely delivery of accurate information in DSURs, and SUSARs to

investigators and Ethics Committees, with the generation of periodic line listings

 Maintain awareness of changes to regulatory guidance documents, requirements and

state-of-the-art pharmacovigilance processes, and make recommendations to improve

effectiveness and maintain compliance

 Regular review, update and implementation of pharmacovigilance business procedures

documented in Standard Operating Procedures, guidelines and User Manuals

 To contribute to the development of training courses for external and internal staff

 Provide relevant subject matter expertise as required for audits and inspections, including

any necessary pre-work in preparation for the audit/inspection, interviews with

auditors/inspectors, as required, and follow-up on any subsequent actions and CAPAs

Experience & Qualifications

Experience & Qualifications:

• Bioscience graduate (BSc, PharmD)
• Fluent in written and spoken English

  Minimum:

• Awareness of pre- and post-marketing PV legislation

• Proven scientific analytical skills

  Ideal:

• Previous experience of pharmacovigilance, either in industry or in a health authority
• Knowledge of product development processes and experience of cross-functional team work
• Sound knowledge of pharmacovigilance legislation
• Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files
• Experience of safety issues related to known target organ toxicities (e.g. hepatic, renal, haematological)

To all agencies: please no phone calls or emails to any employee of Ipsen in relation to this opening. All resumes submitted by search firms/employment agencies to any employee at Ipsen via email or any form of communication/method will be deemed the sole property of Ipsen, unless such search firms/employment agencies were engaged by Ipsen for this position and a valid agreement with Ipsen is in place. In the event a candidate who was submitted outside of the Ipsen agency engagement process is hired, no fee or payment of any kind will be paid.

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.