Predica Inc · 1 day ago
Pharmacovigilance drug safety scientist
United States
Contract
Remote
Mid Level
3+ years exp
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Hiring Manager
Subir Kumar
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Responsibilities
Perform proactive safety monitoring and signal detection for marketed products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation.
Complete initial assessment of safety signals and prepare draft interpretation of reviewed data for assessing safety signals.
Evaluates and prepares documents to answer internal and/or external requests on safety data including the IB, labeling, aggregate reports, and regulatory submissions.
Plan and execute literature surveillance as needed.
Review of RMP/REMS including aRMMs and provide input as needed
Risk Management Activities for post-approval of core/designated core and EU RMPs
Provides input and review for aggregate reports for submission to the health authorities and other stakeholders, as needed. Specifically PBRERs, PADERs, ACOs, local safety summary reports, etc
Review of Local Labeling USPI & SmPC
Representative of Label changes when Global Safety Officers aren’t available
Responsible for responses to Health Authorities’ requests and responses to inquiries from internal and external customers.
Qualification
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Required
3-4 years of experience
HCP (Healthcare professional) background needed
Signal Assessment experience
Minimum 3 years relevant pharmaceutical/biotech industry experience as PV Scientist including at least 5 years’ experience in Pharmacovigilance
Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations and Good Pharmacovigilance (GVP)
Working knowledge of ARGUS
Working knowledge of MedDRA coding
Preferred
Prior authoring of periodic/aggregate reports is helpful but not 100% required
Experience with signaling or other detection tool is helpful
Candidates in ET/CT time zones because some GSL’s are in the UK
The ideal candidate has worked within the following areas: Hereditary angioedema, UC & IBS, Diabetes, Hypertension, Internal Medicine, ADHD, Oncology, Surgical Patches, Wound Healing, Parkinson’s Disease, PPI & Pain Management
Company
Predica Inc
Experienced leaders, architects and consulting experts delivering leading edge business and technology solution.
11-50 employees
H1B Sponsorship
Predica Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (3)
2022 (3)
2021 (1)
2020 (3)
Funding
Current Stage
Early StageCompany data provided by crunchbase
