Aggregate Report Specialist

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title:

Location:

Function:

DESCRIPTION:

The Aggregate Report Specialist creates and quality reviews documents pertaining to both pre-marketing & post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These include but is not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments.

The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Analyzes, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources
• Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities`
• Performing literature search and presentation of relevant articles for the aggregate reports.
• Management and reconciliation of relevant process trackers
• Subject matter expert (SME) along with training and mentoring of individuals
• Generation of Periodic Safety Line Listings (PSLL) from safety database
• Exposure in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
• Providing reliable support for high priority Ad-hoc activities
• Interacting with appropriate client personnel to resolve issues related to the Aggregate reports as per clients’ policies
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines
• Contributes to safety and pharmacovigilance training programs
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
• Training and mentoring of Pharmacovigilance associates

EDUCATION AND EXPERIENCE REQUIRED:

• Minimum 5 years of experience in authoring with at least 3 years of experience in Quality Review of Aggregate Reports
• Degree in Life Science/Pharma or Equivalent

PREFERRED SKILLS:

• Preferred: 5-8 years of experience in authoring with 3-5 years of quality review of Aggregate Reports
• Proficient computer knowledge and computer keyboarding skills.
• Proficient with Microsoft Office Suite (Outlook, Word, Excel).
• Strong verbal, written and interpersonal communication skills.
• Strong organization and prioritization skills; able to multitask.
• Flexibility to adapt and meet fluctuating business priorities.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
• Excellent verbal, written and presentation skills.
• Innovative, collaborative, initiative-taker.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.