Our client is a biotechnology research company, which is focusing on metabolic diseases like diabetes and obesity.
Duties and responsibilities will include but not limited too:
- Development and execution of the safety surveillance strategy and activities for the projects assigned
- Execution of signal detection activities, to support the evaluation and decisions of our client.
- Preparation of high quality periodic safety reports (DSUR, periodic SUSAR reports)
- Preparation of Risk Management Plan (RMP) and/or Risk Evaluation and Minimization Strategies (REMS) documents
- Support the design and execution of the assigned clinical programs from a clinical safety perspective
The successful candidate will have:
- MD degree
- At least 7 years of in-depth, hands-on work experience with drug development in general and in particular with drug safety/pharmacovigilance processes applied in safety surveillance (safety analysis, signal detection and management, DSUR/PSUR, RMP/REMS, internal safety committees, communication with regulatory authorities)
- Solid understanding of the PV (EU and FDA) requirements
- Strong analytical skills
- Ability to communicate and interact maturely with internal and external stakeholders
- Strong ethical standards
- Quality mind-set
- Team-player mindset
We are looking for candidates who are able to provide drug safety expertise to project teams, including all relevant documents prepared for regulatory submissions for the assigned clinical programs.
We are offering a highly competitive salary and benefits package for this position.
If this is of interest please do get in touch.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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