Pharmavise Corporation ยท 1 month ago
Drug Safety Pharmaceutical Consultants
United States
Contract
Remote
Senior Level
5+ years expPharmavise Corporation is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device, and Biotechnology clients. They are seeking a Drug Safety Pharmaceutical Consultant to provide expert consultation in drug safety and pharmacovigilance, ensuring compliance with regulatory requirements while improving patient health and safety.
Food and BeverageHealth Care
Responsibilities
Provide expert consultation and support in drug safety and pharmacovigilance to pharmaceutical companies and regulatory agencies
Review and evaluate adverse event reports and safety data for investigational and marketed drugs, ensuring compliance with regulatory requirements and guidelines
Conduct signal detection activities to identify potential safety concerns associated with drug products and collaborate with cross-functional teams to mitigate risks
Develop and implement risk management plans (RMPs) and risk minimization strategies to optimize the benefit-risk profile of drugs
Provide guidance on safety-related labeling updates, including drafting and review of product labels, package inserts, and risk communication materials
Support regulatory submissions and interactions with health authorities related to drug safety, including responses to safety-related inquiries and requests for information
Contribute to the development and implementation of pharmacovigilance processes and systems to ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH)
Stay abreast of emerging safety issues, pharmacovigilance trends, and regulatory developments in the pharmaceutical industry
Qualification
Required
Advanced degree in pharmacy, pharmacology, life sciences, or related field
Minimum of 5 years of experience in drug safety and pharmacovigilance within the pharmaceutical industry, CRO, or regulatory agency
In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH), including experience with safety reporting requirements (e.g., ICSR, SUSAR)
Strong understanding of pharmacovigilance processes, risk management methodologies, and signal detection techniques
Experience with safety database systems (e.g., ARGUS, ARISg) and adverse event case processing
Excellent analytical and problem-solving skills, with the ability to interpret and communicate complex safety data and risk assessments
Effective communication and collaboration skills, with the ability to interact with internal and external stakeholders, including health authorities
Preferred
Regulatory affairs certification (RAC) or drug safety certification (e.g., CSPV, RPhS) preferred but not required
Benefits
Competitive compensation packages are available.
Company
Pharmavise Corporation
โฆ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒโฆ: ๐๐ก๐๐ซ๐ฆ๐๐ฏ๐ข๐ฌ๐, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ข๐๐ ๐๐๐ข๐๐ง๐๐๐ฌ, ๐๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐ ๐๐ง๐ ๐๐จ๐ฏ๐๐ซ๐ง๐ฆ๐๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐๐ซ๐ญ๐ง๐๐ซ.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
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