Parexel is hiring for Pharmacovigilance Scientist...

Parexel is hiring for Pharmacovigilance Scientist...

Basic Function:
Preparation of aggregate reports and update/preparation of RMPs in accordance with client procedures and regulatory requirements

Parexel is hiring for Pharmacovigilance Scientist...

Principal Functional Responsibilities:

• Preparation of and/or assistance in the preparation of Aggregate Reports including, but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs), addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs) and US Periodic Adverse Drug Experience Reports (PADERs) for pharmaceutical products, in accordance with client SOPs and requirements/ conventions, as required
• Preparation of and/or assistance in the preparation of other reports like Risk Management Plans (RMPs)
• Performing quality check of Aggregate reports/RMPs as per client requirements
• Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high quality work
• Interacting with internal or external contacts to resolve issues related to the assigned work
• Communicating/discussing issues related to the assigned work with the Document Manager/Project Manager
• Mentoring and training new team members on report writing, as required
• Maintaining an awareness of the performance metrics measured by client (where applicable) and striving to remain within established limits
• Maintaining a good working knowledge of the safety profile of assigned drugs, labeling documents, client's guidelines, procedures and SOPs, and international drug safety regulations
• Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines

Note: The above statements describe the general nature and level of work being performed, and are not an exhaustive list of all responsibilities required for the position.

Qualifications

M.Pharm/BDS

Per the requirement, candidate should have experience of 1-2 years of aggregate report writing.

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