Drug Safety Pharmaceutical Consultants

Pharmavise Corporation; United States; Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Remote work

Competitive compensation

Job summary

Pharmavise Consulting Corp. is seeking an experienced Pharmacovigilance professional for a remote role to provide expert drug safety guidance to pharmaceutical clients and regulatory agencies.

You will review adverse event reports, conduct signal detection, and help implement risk management strategies to optimize drug safety profiles. The ideal candidate has 5+ years in PV, deep knowledge of FDA/EMA/ICH regulations, and hands-on experience with safety databases (ARGUS, ARISg).

Qualifications

• 5+ years in drug safety/pharmacovigilance in pharma, CRO, or regulator
• Global pharmacovigilance regulations and ICH guidelines knowledge
• Experience with safety reporting (ICSR, SUSAR)
• Understanding of risk management and signal detection methods
• Experience with safety databases (ARGUS, ARISg) and AE case processing

Responsibilities

• Provide expert consultation on drug safety and pharmacovigilance to pharma clients and regulators
• Review adverse event reports for regulatory compliance
• Conduct signal detection to identify safety concerns and coordinate risk mitigation
• Develop risk management plans and risk minimization strategies
• Advise on safety labeling updates and risk communication materials
• Support regulatory submissions and health authority interactions
• Contribute to PV processes and systems to ensure global compliance
• Stay updated on emerging safety issues and regulatory developments

Skills

Pharmacovigilance expertise

Regulatory knowledge

Analytical skills

Communication skills

Education

Advanced degree in pharmacy/pharmacology/life sciences

Tools

ARGUS

ARISg

Job description

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 atwww.pharmavise.com

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.

Competitive compensation packages are available. Be part of our network of Subject Matter Experts.

EEO Employer: PharmaviseConsulting 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.PharmaviseConsulting 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 . PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you joinPharmavise, you become part of a team that values Excellence Through Quality. Follow us in LinkedInfor more company updates and opportunities.

Originally posted on Himalayas