Mary Tilston at CK Clinical is recruiting for a Safety Scientist to join a company in the pharmaceutical industry at their site based in Basel, Switzerland on a contract basis.
The main purpose of the role will be to:
- Be responsible for carrying out PV activities on a product or group of products including single case medical review, aggregate reporting, signal detection and evaluation and other safety related activities.
- Contribute to PV and Risk Management planning for designated products by preparing the safety surveillance strategy and support the preparation and maintenance of risk management plans as well as preparing and reviewing periodic safety reports (PBRER/PSUR, DSUR, EU renewal and other Annual Safety Reports).
- Conduct/support signal detection and evaluation according to SOPs and guidelines
Further responsibilities will include:
- Carrying out medical review or individual case safety reports (ICSRs) If assigned for the product and prepare safety assessments and drug safety reports as necessary for potential signals or issues. Respond to safety requests from Regulatory Authorities, affiliates or other internal functions regarding assigned products.
- Contributing drug safety input to define and implement the clinical development strategy for a product/group of products including providing safety content review of clinical protocols, study report, investigators brochure and other related documents and contribute to regulatory agency submissions.
- Developing the clinical safety portions of a product development plan in a timely and medically & scientifically sound manner and develop an understanding of the safety profile of the assigned product/s.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to postgraduate degree level in pharmacy or a closely related field or medically qualified (MD).
- Prior industry experience in drug safety, clinical development or medical affairs is desirable with good knowledge of PV practices and US and EU PV regulatory requirements.
- Excellent written and verbal communication skills with good negotiation skills and fluency in English (written and spoken). Good IT skills as well as being self motivated and a strong team player.
This is an excellent opportunity to join a company at the forefront of groundbreaking new medicines, consistently pushing the boundaries of conventional thinking and embracing innovationFor more information or to apply for this position, please contact on Mary Tilston 01438 768717 or email email@example.com. 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 CL31700 in all correspondence.