Safety Analyst

Job Description

Safety Analyst (Intern)

**Good communication is must

This position supports of the Pharmacovigilance (PV) Department as both a key team member and contributor in the scheduling and development of aggregate safety reports, generation of project and safety or signal report specific line listings, risk management materials, and safety data compilation from clinical trials and spontaneous post-marketing reports and other sources.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

- Plays an essential role supporting PV Operational Delivery to facilitate and meet client project deadlines for various aggregate and signal reports, line listings, and safety data compilation as required by client.
- Manages the operational aspects of aggregate safety reporting. Provides pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of Periodic Adverse Drug Experience Reports (PADER)
- Support drafting of assigned sections of other aggregate reports like Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Evaluation Reports (PBRER), Annual Safety Reports (ASR), and IND Annual Reports and client specific signal detection reports.
- Generate aggregate reports line listings as required to meet regulatory requirements and contracted deliverables for client projects
- Collaborates with various stakeholders to ensure that outputs from the safety database meets the need for preparation through submission of aggregate safety reports, while maintaining compliance with regulatory timeline(s).
- Thorough understanding and adherence to aggregate safety reporting processes and procedures, safety management plans (SMP), and safety data exchange agreement(s) (SDEA) / Pharmacovigilance Agreement(s) (PVA).
- Knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis, benefit-risk assessment, drug development, and post-marketing requirements.
- Familiar with safety database(s) (e.g., ARGUS, ARISg) and MedDRA.
- Strong attention to detail with a proactive persistence approach to following tasks through to completion.
- Support PV Operations, PV audits and inspections
- Draft other safety writing deliverables as needed.
- All other duties as assigned.
- Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
- All other duties as assigned.

EXPECTIONS OF THE JOB:

- Responsible to deliver CLIENT DELIGHT
- Responsible to identify, deploy, oversees, mentor direct reports and consultants supporting various clients
- Responsible to work collaboratively with EVERSANA PV team and take direction and feedback from management and clients
- Responsible to ensure management and compliance with industry standards and codes of practice
- Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical, and compliant medical content
- Responsible to proactively flag and manage any quality issues, and ensure timely corrective and preventive actions

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

- BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
- Strong attention to detail, teamwork, and initiative
- Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance
- Familiarity with FDA and international adverse event reporting regulations per ICH guidelines
- Understanding of medicalterminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus
- Must be quality oriented and demonstrate consistent attention to detail
- Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required

---