This is a remote position.
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at
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.
Qualifications:
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.
Regulatory affairs certification (RAC) or drug safety certification (e.g., CSPV, RPhS) preferred but not required.
This is a challenging and rewarding opportunity for individuals passionate about drug safety and patient well-being. Competitive compensation packages are available.
Be part of our network of Subject Matter Experts.
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com .
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise , you become part of a team that values Excellence Through Quality.
Follow us in LinkedIn for more company updates and opportunities.
...Empire State Development, NYS Title Intern, Cybersecurity Occupational Category... ...assessing system, network, and application security risks- Support vulnerability scanning,... ...documentation efforts- Conduct research on emerging cyber threats, technologies, and regulatory...
...Emerson-Hubbard Community School is seeking applicants for a 6-12 grade Social Studies teacher for the 2026-2027 school year. E-H offers small class sizes, and a professional environment devoted to supporting teachers with their unique professional needs. We are considering...
...Challenge?Looking for an innovative organization and the opportunity tolearn and grow professionally? We can help! We are seeking an Interior Designer, under the Temporary Professional StaffingServices contract with the Department of Veterans Affairs. This project will...
...includes creating user-friendly interfaces, customizing portal widgets, developing workflows, and integrating with existing systems. ~ The ideal candidate will have a strong background in ServiceNow development, excellent problem-solving skills, and the ability to work...
...You could be the one who changes everything for our 28 million members. Centene is transforming the health of our communities, one person at a time. As a diversified, national organization, youll have access to competitive benefits including a fresh perspective on workplace...