At a Glance
- Tasks: Manage pharmacovigilance cases and ensure timely regulatory reporting.
- Company: Join a leading pharmaceutical organisation near Cambridge, MA.
- Benefits: Competitive hourly rate, comprehensive healthcare, and employee discounts.
- Other info: Onsite contract position with potential for extension.
- Why this job: Make a real difference in patient safety and drug efficacy.
- Qualifications: Bachelor’s degree in science or healthcare and 4+ years in pharmacovigilance.
The predicted salary is between 40000 - 48000 € per year.
The Scientific Team at Russell Tobin / Pride Health is hiring a Pharmacovigilance Specialist for a top pharmaceutical organization near Cambridge, MA.
Responsibilities:
- Triage, Intake, case entry and QC of ICSRs originating from Biogen sponsored studies or other assigned cases. Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders.
- Perform retrospective quality checks on processed cases.
- Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting.
- Review and resolution of reconciliation issues between the clinical and safety databases in collaboration with Data Management.
- Provide investigation details into late regulatory reporting of CT cases.
Requirements:
- Bachelor’s degree in science or healthcare related field.
- 4+ years experience in pharmacovigilance.
- Knowledge of Global and local safety regulations.
- Excellent written and verbal communication skills.
- Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva.
- Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance.
- Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required.
Additional Details:
- Onsite position.
- Position Type: contract position through the end of the year with potential for extension.
- Salary range approved: $50-60/hr depending on experience.
- Must be authorized to work in the United States.
Pride Global and its affiliates, including Russell Tobin, Pride Health, Pride Now, and Pride One, offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.
Equal Employment Opportunity: Pride Global and its affiliates are an equal opportunity employer. We do not discriminate on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
Fair Chance Employment: Pride Global and its affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including the California Fair Chance Act and all applicable local Fair Chance ordinances.
Accommodations: We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.
Pharmacovigilance Specialist employer: Pride Health
At Russell Tobin / Pride Health, we pride ourselves on fostering a supportive and inclusive work environment that prioritises employee well-being and professional growth. Located near the vibrant city of Cambridge, MA, our team enjoys access to comprehensive healthcare benefits, a robust 401(k) plan, and various employee discounts, all while contributing to meaningful projects in the pharmaceutical sector. Join us to be part of a dynamic team where your expertise in pharmacovigilance will be valued and where you can thrive in your career.
StudySmarter Expert Advice🤫
We think this is how you could land Pharmacovigilance Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and join online forums. The more people you know, the better your chances of landing that Pharmacovigilance Specialist role.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Show them you’re not just another candidate; you’re genuinely interested in their work and how you can contribute as a Pharmacovigilance Specialist.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to pharmacovigilance. We all know that confidence is key, so the more you rehearse, the more comfortable you'll feel during the real deal.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect with us directly.
We think you need these skills to ace Pharmacovigilance Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Pharmacovigilance Specialist role. Highlight your relevant experience in pharmacovigilance, especially any work with ICSR processing and safety database systems like ArisG or Argus.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Use specific examples from your past experiences that align with the responsibilities mentioned in the job description.
Showcase Your Communication Skills:Since excellent written communication is key for this position, ensure your application is clear, concise, and free of errors. This is your chance to demonstrate your attention to detail!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role without any hiccups.
How to prepare for a job interview at Pride Health
✨Know Your Stuff
Make sure you brush up on pharmacovigilance principles and the specific regulations like FDA, ICH, and EU guidelines. Familiarise yourself with ICSR processing and the safety database systems mentioned in the job description, such as ArisG and Argus.
✨Showcase Your Experience
Prepare to discuss your 4+ years of experience in pharmacovigilance. Have specific examples ready that highlight your case management skills, narrative writing, and how you've handled quality checks or reconciliation issues in the past.
✨Communicate Clearly
Since excellent written and verbal communication skills are a must, practice articulating your thoughts clearly. You might be asked to explain complex medical concepts, so being able to simplify these for different audiences will be key.
✨Be Ready for Scenario Questions
Expect questions that put you in real-world scenarios related to case entry and QC processes. Think about how you would handle tight deadlines or unexpected issues, especially around weekends and holidays, and be prepared to share your thought process.
