The groups we serve include managed care organizations, biopharmaceutical companies, governmental agencies, physicians and other healthcare providers, hospitals and health systems, employers, patients and consumers, contract research organizations, and independent clinical laboratories.
Post : Project Manager Drug Safety
• 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
Experience : 7 to 8 years
Qualification : B.Pharm, B.Sc
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
End Date : 10th November, 2021
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