Drug Safety Regulatory Compliance Mngr
Hendre Moolman at CK Clinical is recruiting for a Drug Safety Regulatory Compliance Manager to join a global pharmaceutical company at their site based in Slough on a contract basis.
Your main responsibilities in this role will be:
- Distribution of individual case reports to affiliates according to required timelines
- Submission of individual case reports from clinical studies to Regulatory Agencies, investigators, Ethics Committees as required by regulations
- Submission of required line listings and Development Safety Update Reports to Regulatory Agencies, investigators, Ethics Committees as required by regulations
- Preparation of a schedule of required Periodic Safety Update Reports, Development Safety Update Reports, Risk Management Plans, risk analyses to support benefit risk assessments and other such reports and that the requirements are known to the therapeutic area staff and medical writing teams
- Preparation, review of individual case compliance reporting analyses, obtaining responses to such reports from affiliates and tracking associated CAPA plans
- To maintain the records of study blind envelopes and other randomisation lists in a regulatory compliant manner and maintaining confidentiality so as to ensure study integrity.
- To work cross functionally within project teams to meet Company objectives and to represent the Central Department of Pharmacovigilance in a team oriented manner and delivering quality and timely input to meet the needs of the project team
- To ensure that electronic systems are maintained as required.
You are required to have the following qualifications, skills and experience:
- Medical sciences or pharmacy degree
- Knowledge of regulatory requirements pertaining to pharmacovigilance in the pre and post approval environments
- Fluent in English
- Excellent verbal, written, interpersonal, negotiation and influencing communication skills
- Ability to work in a matrix and remote organization and international cross-functional teams
- Strong focus on producing key deliverables (quality/time/costs)
- Proven ability to work in validated databases
- Well developed time management, communication, presentation, analytical and influencing skills.
- Ability to present complex data in an understandable format
- Responsible, flexible and accountable with proactive approach.
- Ability to plan, prioritise and delegate work.
If you are employed by this client you will be joining a global pharmaceutical company based in Slough. Other benefits include:
- Competitive rate
For more information or to apply for this Drug Safety Regulatory Compliance Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31431 in all correspondence.