other
Posted 3 weeks agoAssociate Director PSS, Canada Remote Based
at Fortrea
Toronto, CanadaRemote
Responsibilities
- Ensure efficient, effective, and economic operation of PSS including management of quality, regulatory compliance, and adherence to project budgets.
- Ensure timely and appropriate reporting of expeditable adverse events to clients, regulatory authorities, ethics committees and investigators, as required.
- Support Business Development (BD) activities including client presentations and accurate input for costings and proposals.
Requirements
- Qualifications (Required) RN + 10 yrs. relevant experience BS/BA + 8 yrs. relevant experience MS/MA + 6 yrs. relevant
- experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety.
- To be considered for this position, candidate must possess relevant
- experience specifically in safety/AE processing) along with a minimum of 4 years’ supervisory
- Language Skills Required: Speaking: English and local language.
- experience of which 6+years are relevant to drug safety knowledge. Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation. Knowledge of worldwide regulatory
- Knowledge of ICH guidelines.
- Knowledge of Medical Device reporting is desirable.
- Knowledge of Periodic Safety Update Report (PSUR) desirable.
- experience in the pharmaceutical, biotechnology or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.