Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post: Drug Safety Manager (Pharmacovigilance)
Job Description:
- Line manage PV&DSS staff including performance reviews, human resource issues, and assist Senior PV&DSS Management in assigning resources to projects.
- Manage the overall PV&DSS 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.
Candidate Profile:
- At least 2 years experience in line management and/or project management experience
- Relevant working experience in pharmacovigilance/drug safety is a must
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level
- Leadership capabilities
- Anticipate/ identify problems and takes appropriate action to correct
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
- Knowledge of Medical Device Reporting desirable
- Knowledge of aggregate reporting desirable
- Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance
Additional Information:
Experience: 2 years
Location: India
Education: Any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
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