Pharmacovigilance Scientist
Company: CONTINUUM India LLP
- Location: Chandigarh, India
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Job description
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 serious 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
Please refer to the requirements specified below for this ongoing PV opportunity-
- Candidates with 2-5 years' PV experience in triage, data entry, quality review and submission of ICSRs can also apply.
- Immediate joiners preferred
- Available to work from Chandigarh office.
