Pharmacovigilance Specialist

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it's about more than just a job-it's about your career and your future.

Your Role

This position can be remote, but candidates should reside in the West Coast.

• Ensure regulation compliance and timely integration while managing the receipt, evaluation, and processing of adverse event reports. Ensure cases are efficiently processed into the safety database.
• Handle cases while ensuring the timely intake, processing, and submission to regulatory agencies of individual case safety reports.
• Review clinical trial and post-marketing safety information and assist in the preparation of periodic safety reports, and other documents, as needed.
• Import and monitor E2B and facilitate prompt and effective communication with partners and team members regarding any potential importation and transmission issues.
• Identify any Individual Case Safety Reports (ICSR) and extract relevant information from research/ literature articles for safety data processing.
• Enter post-marketing and clinical ICSRs data to the relevant safety databases.
• Execute adverse event reconciliation.
• Maintain the ICSR case files and data and other related safety documentation.
• Oversee drug safety mailbox.
• Identify any new safety reports to protect patients and maintain full compliance with regulatory requirements.
• Additional duties may be assigned time from time.

Requirements

• Bachelor's degree in the life sciences.
• Minimum of 2 years of drug safety experience.
• Advanced knowledge of FDA regulations including safety reporting requirements.
• Experience in combination product reporting requirements is preferred.
• Experience with systems and network monitoring applications and workflows.
• Strong knowledge and experience with SDLC validation.
• Experience with pharma documentation (SOPs, guidelines, safety plans, etc.)
• Excellent communication skills both written and verbal.
• Strong analytical and problem-solving skills.
• Advanced knowledge of computer/word processing.

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Pay Range (dependent on experience) $93,000-$115,000

Equal Opportunity Employment Statement:

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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