Senior Pharmacovigilance & Risk Management Scientist (Remote)

ProPharma

England

Hybrid

GBP 60,000 - 90,000

Full time

14 days+

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Job summary

ProPharma is seeking a senior Pharmacovigilance professional to lead and refine risk management activities. You will author and review PSURs, PBRERs, and DSURs, and drive quality for regulatory submissions.

The role leverages your expertise in RMPs, signal detection, and literature screening, with a strong client-facing and audit-ready mindset. You will mentor juniors, manage data extraction and line listings, and ensure timely delivery of high-priority safety deliverables in a hybrid work

Qualifications

5+ years of experience in Pharmacovigilance with a focus on Risk Management Plans.
Bachelor/Master's Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience.
Experienced in presenting metrics and leading discussions about quality internally and with Client.
Well-rounded experience in literature screening activities and/or authoring and reviewing aggregate reports and/or experiences in authoring and updating RMPs and/or significant knowledge of signal detection methodologies and/or exp managing CCDSs and knowledge of regulatory safety variation processes

Responsibilities

Authoring and Quality review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
Authoring and review of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
Authoring and Quality review of Signal Management Reports.
Performing literature search and validity check for the aggregate reports.
Management and reconciliation of relevant process trackers.
Subject matter expert (SME) along with training and mentoring of individuals.
Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
Generation of Line Listings (LL) from safety database and Quality check of the line listings when required.
Providing reliable support for high priority Ad-hoc activities.
Literature (Clinical & non-clinical, scientific) validity check, duplicate search in the respective tool for literature review.
Participating in internal/ external audits/ inspections as SME, if required.
Interacting with appropriate client personnel to resolve issues related to assigned activities.
Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
Independent planning and execution of tasks such as preparation of an aggregate report.