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Drug Safety Pharmaceutical Consultants

5+ years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Drug Safety Pharmaceutical Consultants

Company: Pharmavise Corporation
Location: Maple Grove, MN, USA
Job Type: Remote

About Us:
From development to commercialization, we partner with Pharmaceutical, Medical Device, and Biotechnology clients to provide solutions to complex compliance issues. Our mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at
www.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 reviewing 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.

Equal Employment Opportunity (EEO) Statement:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, age, sexual orientation, gender identity, national origin, ancestry, disability, veteran status, or any other characteristic protected by law. We consider qualified applicants with criminal histories in accordance with applicable law. If you require accommodation in using our website for job applications, please contact
info@pharmavise.com.

About Pharmavise:
Pharmavise Consulting Corp. is a regulatory compliance consulting firm partnering with Pharmaceutical, Medical Device, and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

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