Parexel Pharmacovigilance Job Opening – Pharma Candidates Apply
Pharmacovigilance Pharma Job. Parexel Invites Pharma Candidates, Pharmacovigilance Post Vacancy. Parexel invites Candidates for the post of Associate. Candidates with a postgraduate degree in Pharmacy may walk-in for this post on the mentioned date. Check out all the details
Job Title: Pharmacovigilance Scientist
Job ID 58336BR
Location: Chandigarh, Chandigarh, India
Preparation of aggregate reports and update/preparation of RMPs in accordance with client procedures and regulatory requirements
M.Pharm Per the requirement, the candidate should have experience of 1-2 years of aggregate report writing.
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.
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