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Propharma Group
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Pharmacovigilance Safety Scientist

Pharmacovigilance Safety Scientist

Propharma Group

2 - 5 years

4 - 5 Lacs

kolkata mumbai new delhi hyderabad pune chennai bengaluru

Posted:1 day ago| Platform:

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Skills Required

nursing gcp pharma analytical pharmacy consulting clinical research wellness pharmacovigilance medical writing

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Pharmacovigilance (PV) Scientist supports the activities in the Benefit Risk group by ensuring that day-to-day operational activities are completed. The PV Safety Scientist is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. The PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company.

Essential functions

Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
Authoring of Signal Management Reports.
Performing literature search and validity check for the aggregate reports.
Reconciliation of relevant process trackers.
Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
Generation of Line Listings (LL) from safety database
Providing reliable support for high priority Ad-hoc activities.

Necessary Skills and abilities.

Analytical and problem-solving skills.
Sound organizational skills
Able to work within a team in an open and professional manner
Excellent attention to detail and focus on quality
Understanding of ICH-GCP, FDA, EMA and other relevant Global regulations related to PV
Demonstrable ability to analyze and quantify large volumes of data in a concise and scientific manner, in keeping with regulatory deadlines.
Awareness of global culture and willingness to work in a matrix environment
Knowledge in other pharmacovigilance processes, ability to author/update SOPs or WIs, to identify and author deviations/CAPAs."
Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
Computer proficiency, IT skills, expertise and an ability to work with web based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Educational requirements

Bachelor/master s degree in pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

Experience Requirements

2+ years experience in Pharmacovigilance with a focus on medical writing and/or literature search and/or signal detection
Experiences in contributing to the compilation of metrics and participating in discussions about quality internally and with Clients
Experience in literature screening activities and/or experiences in authoring and reviewing aggregate reports

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Pharmacovigilance Safety Scientist