Drug Safety Pharmaceutical Consultants Job at Pharmavise Corporation, Florida

Y1B3dFdGdkpoWWEyNmlQTUVBYko0dStaZWc9PQ==
  • Pharmavise Corporation
  • Florida

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 at   

 

Responsibilities:  

  1. Provide expert consultation and support in drug safety and pharmacovigilance to pharmaceutical companies and regulatory agencies.  

  2. Review and evaluate adverse event reports and safety data for investigational and marketed drugs, ensuring compliance with regulatory requirements and guidelines.  

  3. Conduct signal detection activities to identify potential safety concerns associated with drug products and collaborate with cross-functional teams to mitigate risks.  

  4. Develop and implement risk management plans (RMPs) and risk minimization strategies to optimize the benefit-risk profile of drugs.  

  5. Provide guidance on safety-related labeling updates, including drafting and review of product labels, package inserts, and risk communication materials.  

  6. Support regulatory submissions and interactions with health authorities related to drug safety, including responses to safety-related inquiries and requests for information.  

  7. Contribute to the development and implementation of pharmacovigilance processes and systems to ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).  

  8. Stay abreast of emerging safety issues, pharmacovigilance trends, and regulatory developments in the pharmaceutical industry.  

 

Qualifications:  

  1. Advanced degree in pharmacy, pharmacology, life sciences, or related field.  

  2. Minimum of 5 years of experience in drug safety and pharmacovigilance within the pharmaceutical industry, CRO, or regulatory agency.  

  3. In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH), including experience with safety reporting requirements (e.g., ICSR, SUSAR).  

  4. Strong understanding of pharmacovigilance processes, risk management methodologies, and signal detection techniques.  

  5. Experience with safety database systems (e.g., ARGUS, ARISg) and adverse event case processing.  

  6. Excellent analytical and problem-solving skills, with the ability to interpret and communicate complex safety data and risk assessments.  

  7. Effective communication and collaboration skills, with the ability to interact with internal and external stakeholders, including health authorities.  

  8. 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.  

 

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.



Job Tags

Contract work,

Similar Jobs

CU* Answers

Help Desk Specialist Job at CU* Answers

 ...drivers license required. CU*Answers is an Equal Employment Opportunity employer that supports the unique perspectives and experiences from all employees and supports a collaborative community spirit. All qualified applicants will receive consideration for employment... 

Rezolute, Inc.

Associate Director - Patient Affairs Job at Rezolute, Inc.

 ...hyperinsulinism (tumorHI). Position Summary The Associate Director of Patient Affairs will play a pivotal role in engaging and supporting...  ...events. Support the integration of real-world patient experiences into evidence generation and publication activities.... 

Lakeview Lending LLC

Entry Level Mortgage Loan Officer Job at Lakeview Lending LLC

 ...where to start? We are seeking motivated individuals to join our Entry Level Loan Officer Program! This is an Hourly + Performance Bonus's,...  ...diploma or equivalent required. College degree in finance or banking preferred Dial leads throughout the dayAbout Company:... 

Solutions Physical Therapy & Sports Medicine

Physical Therapy Aide - Part-Time - Alexandria, VA Job at Solutions Physical Therapy & Sports Medicine

 ...About Solutions Physical Therapy & Sports Medicine: At Solutions Physical Therapy & Sports Medicine, we're not just a team; we're a community that's guiding people to a better life. We are dedicated to providing personalized care that addresses the whole person, not... 

Zortech Solutions

Senior React Developer Job at Zortech Solutions

Senior React Developer Jersey City New Jersey (Onsite) W2 Candidates only Looking for a very strong UI developer React/Typescript/Cypress/GIT MUST HAVE Should have some experience with wireframes "#L!-CEIPAL"