As Aggregate Report Physician
Prepare and distribute aggregate report as per client requirement.
Coordinate all internal and external PSUR activities to be carried out
Oversee overall Pharmacovigilance (PV) and risk management activities.
Provide expert guidance in PV and Aggregate reporting areas.
Coordinate all post marketing regulatory reporting and PV activities for assigned products
Prepare and review scheduled Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Agencies) Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports.
Prepare and review responses to adhoc regulatory queries.
Appropriate scientific interpretation of relevant information for inclusion into drug safety documents, prepare and write analytical aggregate reports and other drug safety medical documents.
Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR.
Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.
Creating all documents in accordance to applicable Standard Operating Procedure (SOPs), conventions, and regulatory requirements.
Planning, organizing, and managing daily work to meet service level timelines and deliverables.
Work with the Aggregate Reporting team lead to escalate issues or tasks outside the normal scope of work.
Participate in internal and external audits and inspections by clients and health authorities.
SPECIALIZED KNOWLEDGE AND SKILLS:
Ability to interpret, analyze and clearly present scientific and technical data in verbal and written format.
Preparation, analysis and writing of ad hoc and aggregate regulatory reports and labeling support document.
Knowledge of global post marketing safety reporting regulations and guidance.
Experience with relevant safety databases and related software applications.
Good understanding of drug safety.
Relevant product and industry knowledge.
Working knowledge of Good Pharmacovigilance Practice (GVP) modules.
Effective communication, organization, and time management skills.
Good interpersonal skills and the ability to operate effectively in an international environment.
English language proficiency is a must.
High degree of accuracy and attention to detail.
Requires a proactive approach and excellent written/oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively.
Effective cross department communication.
Ability to document and communicate problem/resolution and information/action plans.
DESIRED TECHNICAL SKILLS:
Should be familiar with MS Office tools/Safety database and related Software.
Ability to educate/ train the team members as needed.
Contributing to the ongoing enhancement of Pharmacovigilance process and SOPs including internal and external training.
Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
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