The Pharmacovigilance Information Specialist (PVIS) for GPIO (Global Pharmacovigilance Information Office) will research, review, and maintain information related to expedited and periodic safety reporting requirements for both clinical trial studies and post market projects. The PVIS works to ensure company and client compliance with relevant national and regional drug/ device safety regulations and Standard Operating Procedures (SOPs).

Responsibilities:

• Responsible for researching and maintaining drug and device safety reporting related regulatory intelligence.

• Accountable for country safety requirement reviews and updates for assigned countries, accountable for supporting team members with QC of country reviews; and act as back for other team members, as required.

• Liaise and communicate with Regulatory Authorities, Ethics committees, local safety contacts etc. to obtain safety regulatory updates relevant to safety reporting.

• Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs.

• Responsible for responding to questions and queries regarding safety reporting requirements as per relevant SOPs.

• Collaborating with and assisting the Global Pharmacovigilance Intelligence Office (GPIO) team in operational day-to-day activities.

• Participating in functional internal and external team meetings, as needed.

• Ensuring that work completed meets the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings for regulatory intelligence for both internal and external stakeholders.

• Providing functional expertise/oversight of safety reporting requirements to PV Operations staff (both pre and post-marketing setting).

• Prepare for, participate and respond to internal/external audits/inspections, as needed.

• Maintaining up-to-date knowledge of relevant regulations and client’s and Parexel’s Standard Operating Procedures

• Other tasks as required by the management from time to time.

Skills:

• Sound knowledge of expedited and periodic drug safety reports required by RA, EC and Investigators

• Sound knowledge of the drug development process

• Knowledge of and ability to interpret and apply global safety regulations

• Experience in reading/ researching legislations and guidance documents

• Good presentation/ verbal and written communication skills

• Analytical and problem-solving skills

• Excellent interpersonal skills

• Excellent organizational and prioritization skills

• Ability to work collaboratively and effectively in a team environment

• Client focused approach to work

• Experience with computer applications including database management

Knowledge and Experience:

• Experience working on reporting expedited or periodic safety reports to Regulatory Authorities/ Ethics committees or Investigator is preferable, or experience with processing safety reports in the safety database.

• Experience with clinical trial or post market drug safety studies/ projects.

Education:

• Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience