Drug Safety Pharmaceutical Consultants

Pharmavise Corporation•Maple Grove, MN

15d•Remote

About The 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 www.pharmavise.com

Requirements

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.

Nice To Haves

Regulatory affairs certification (RAC) or drug safety certification (e.g., CSPV, RPhS) preferred but not required.

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.