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Remote WFH Job Parexel – Life Sciences Apply For PV Information Specialist

PV Information Specialist GPIO

Location: India (Remote)

Additional Locations: SAS Nagar (Mohali), Punjab, India

Job ID: R0000021214

Category: Medical Sciences

About This Role:

The Pharmacovigilance Information Specialist (PVIS) for GPIO (Global Pharmacovigilance Information Office) is responsible for researching, reviewing, and maintaining information related to expedited and periodic safety reporting requirements for clinical trial studies and post-market projects. The PVIS ensures compliance with national and regional drug/device safety regulations and Standard Operating Procedures (SOPs).

Responsibilities:

  • Research and maintain drug and device safety reporting regulatory intelligence.
  • Review and update country safety requirements for assigned countries and support team members in quality control of country reviews.
  • Liaise and communicate with regulatory authorities, ethics committees, and local safety contacts to obtain safety regulatory updates.
  • Update relevant databases, repositories, trackers, and logs as per SOPs.
  • Respond to questions and queries regarding safety reporting requirements.
  • Collaborate with the GPIO team in day-to-day operations.
  • Participate in functional internal and external team meetings, as needed.
  • Ensure work meets Service Level Agreements and Key Performance Indicators for quality, compliance, and trainings.
  • Provide functional expertise and oversight of safety reporting requirements to PV operations staff.
  • Prepare for and participate in internal/external audits and inspections, as needed.
  • Maintain up-to-date knowledge of relevant regulations and SOPs for clients and Parexel.

Skills:

  • Knowledge of expedited and periodic drug safety reports required by regulatory authorities, ethics committees, and investigators.
  • Familiarity with the drug development process and the ability to interpret and apply global safety regulations.
  • Experience in reading/researching legislation and guidance documents.
  • Good presentation, verbal, and written communication skills.
  • Analytical and problem-solving abilities.
  • Strong interpersonal skills.
  • Excellent organizational and prioritization skills.
  • Collaborative and effective team player.
  • Client-focused approach to work.
  • Experience with computer applications, including database management.

Knowledge and Experience:

  • Experience with reporting expedited or periodic safety reports to regulatory authorities/ethics committees/investigators or processing safety reports in safety databases.
  • Experience with clinical trials or post-market drug safety studies/projects.

Education: Degree in pharmacy, nursing, life science, or other health-related fields, or equivalent qualifications/work experience.

APPLY ONLINE HERE

Keywords: PV information specialist, drug safety reports, pharmacovigilance, regulatory compliance, clinical trials. Remote WFH Job Parexel – Life Sciences Apply For PV Information Specialist. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram.

Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.