- Manage ‘Client’ or ‘Project’ specific PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports) for specified projects.
- Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
- Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
7 to 8 years of relevant experience
EudraVigilance Certification preferred
- Compliance with client and global regulatory requirements
- Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
- Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Good knowledge of ICH guidelines.
- Good knowledge of medical and drug terminology
- Work collaboratively with PSS Management’s team
- Good verbal, written and presentation skills.
- Good communication.
- Leadership capabilities
- Anticipate/identify problems and takes appropriate action to correct.
- Knowledge of Medical Device Reporting desirable
- Knowledge of aggregate reporting
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Financially intuitive
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