Other Locations:UK- Stockley Park
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- To oversee and lead all local pharmacovigilance related activities as directed by the UK and Ireland Drug Safety and Risk Management Manager.
- Ensure compliance with local and international regulations and Celgene’s internal standards.
- To lead and execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development (when needed).
- To lead and execute timely and accurate reporting to the national competent Authorities.
- To contribute effectively as part of the Celgene Global Safety network.
- To assist the UK and Ireland Drug Safety and Risk Management Manager by accurately and thoroughly training and mentoring junior members of staff to ensure compliance within the Drug Safety and Risk Management Department in the affiliate.
- To represent the Drug Safety and Risk Management Department within the affiliate as a point of reference internally.
- Under the supervision of the UK and Ireland Drug Safety and Risk Management Manager, develop the Drug Safety and Risk Management Function within the affiliate.
Role and Responsibilities
- Lead the quality review of electronic Risk Management Programme system data output against paper PAFs.
- Assist with the preparation and review of Risk Management processes and documentation including SOPs/WPs and PPP periodic reports.
- Lead Preparation, review and distribution of PPP educational materials in accordance with GDSRM - EMEA/APAC.
- Prepare and submit PPP related report to the National Competent Authorities in the UK and Ireland.
- Comply with the conditions of the Marketing Authorisation of Celgene Products through preparation, planning and the implementation of Celgene PPP in accordance with local and international legislation and the agreed timelines.
- Support implementing measures to assess the compliance rate and effectiveness of the PPP in the UK and Ireland.
- Support the DSRM Manager in Risk Minimisation in Affiliate led Organised Data Collection Schemes to support GDSRM’s oversight, including but not limited to:
- Risk Minimisation Programme compliance and effectiveness measures, regarding those product/indications for which a corresponding module is not available/functioning in the AIFA Oncology Registry.
- Other projects, such as PASS and PAES where applicable e.g. provision of Additional Educational Materials for Risk Minimisation.
- Pre-approval Access e.g. implementation and maintenance of applicable Risk Minimisation Programme.
SAE/AE Case Processing
- To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports from clinical trials and from post marketing sources.
- To maintain current awareness of local and global safety regulations.
- To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing the safety database.
- To contribute to the development and maintenance of standard operating procedures and associated documents on safety data handling.
- To maintain current awareness of the safety profile of the development and/or marketed company portfolio and their most relevant competitors.
- To maintain current awareness of the current product labelling on all Celgene’s products (IB, National, SPC, Core label, US PI).
Internal affiliate development
- Support DSRM Manager in Affiliate led Organised Data Collection Schemes to support GDSRM’s oversight, including but not limited to:
- Non interventional studies.
- Patient Support Programs.
- Market Research Surveys (review of surveys/questionnaires and protocols, contracts and vendor training).
- Other projects such as PASS and PAES where applicable.
- Pre-approval access (e.g. Compassionate Use, Named Patient Programs)
- Interventional & non-interventional IIT protocols, CRFs, ICFs and contracts review.
- IITs Sponsors/CROs training.
- Support DSRM Manager, to provide PV input/safety reporting training to Investigator Meetings including IITs and Celgene Sponsored (if applicable).
- Support the reconciliation of DSURs/ASRs (periodic aggregate reports).
- To assist with training of the affiliate organisation and associated third parties on safety data reporting and Risk Management PPP requirements.
- To capture, follow-up and ensure the appropriate persons within Celgene are notified of locally reported Product Quality Complaints.
- To ensure up to date filing and maintenance of all internal SOPs, ensuring appropriate training program is in place.
- To provide advice on pharmacovigilance issues to other internal departments, or regional project teams.
- To prepare/review/present pharmacovigilance documentation for internal and external customers and to represent the affiliate Drug Safety and Risk Management Department on a company level under the supervision of the UK and Ireland Drug Safety and Risk Management Manager.
- To mentor and develop more junior colleagues, driving development of the drug safety and Risk Management function to add value to the affiliate organization.
- Uphold and promote the company externally by demonstrating high professional standards and integrity in all external contacts.
Skills and Knowledge Requirements
- Life science/Pharmacy degree or Registered Nurse.
- Relevant experience within a Pharmaceutical company or CRO.
- Ability to lead projects under the supervision of the UK and Ireland Drug Safety and Risk Management Manager.
- Ability to follow standard operating procedures.
- Be able to work independently and as part of a team.
- Strong identification with Celgene’s values.
- Excellent written and verbal communication skills.
- Attention to detail.