for Experienced PV Scientist role-

Basic Function:

Responsible for processing of Individual Case Safety Reports (ICSRs), preparation of aggregate reports and activities related to signal management.

Principal Functional Responsibilities

Manage activities relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and responsible adverse events (SAEs) in ICSRs for marketed and investigational human and veterinary products in accordance with the applicable regulatory requirements

Preparation of Scheduled and Unscheduled Aggregate report [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports

(PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs),

Signal Evaluation Reports (SERs)] from aggregate data for products, in accordance with client conventions and requirements

Quality checks of aggregate reports

Signal detection-related analyses and reports including cumulative analyses, issue event analyses

Interacting with internal or external contacts to resolve issues related to the processing of ICSRs, aggregate reports and related processes

Maintaining a good working knowledge of the Adverse Event (AE) safety profile of assigned drugs, labelling documents, data capture conventions,

guidelines, client procedures and international drug safety regulations

Maintaining an awareness of global regulatory reporting obligations 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 and Experience:

Science/Medicine degree: The minimum qualification required would be a Masters degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.), Pharm D candidates can also apply.

A degree in Dentistry would be an advantage (BDS, MDS)

Experience in pharmacovigilance/drug safety or allied fields would be an advantage

Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite

(Word/Excel/ Power Point)

Good knowledge of medical terminology

Fluency in written and spoken English

Ability to evaluate data and draw conclusions independently

Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text

High level of flexibility and ability to (re)prioritize work

Typing and transcription accuracy

Attention to detail

Team Player

Experienced job seekers please refer to the requirements specified below for this ongoing PV opportunity -

1. Must have case processing experience of 2 years to 5 years
2. Experienced in triage, data entry, quality review and submission of ICSRs
3. Experienced in Oracle Argus Safety One
4. Flexibility required to support safety operations for US based clients
5. Immediate joiners preferred or up to 2 months' notice period can apply
6. Hybrid mode of work

📌 Experienced PV Scientist (Chandigarh)
🏢 CONTINUUM India
📍 Chandigarh