Regulatory Intelligence Associate

4 weeks ago

Sydney, Australia Sitero LLC Full time

**_Regulatory Intelligence Associate (Contractor - Remote)_**

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: Regulatory Intelligence Associate**

**Location: Hybird**

**Function: Drug Safety Services**

***

**DESCRIPTION**:
Regulatory Intelligence Associate is a professional responsible for managing all PV related intel relating to new and ongoing developments in the regulations governing the formulation and reporting of safety events (ICSR, PSUR, DSUR etc)

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**:

- Play an active role in global regulatory intelligence activities, such as monitoring, acquiring, tracking, and categorizing information pertaining to the changing global regulatory landscape within the Life Science industry.
- Update the team to new and ongoing developments in the regulations governing the formulation and reporting of safety events (ICSR, PSUR, DSUR etc)
- Perform review of regulatory intelligence items received from various other sources including Cortellis and Global Regulatory Policy (GRP) on a regular basis.
- Perform regular follow-ups with SMEs as necessary to confirm resolution of updates made based on the reported regulatory intelligence.
- Responsible for maintenance of all regulatory correspondence and submission acknowledgements
- Participate in shaping the automation, tools, and processes supporting regulatory intelligence operations.
- Develop working knowledge of quality compliance and regulatory intelligence relevant to assigned projects, including structuring and analyzing compliance data.
- Capable of analyzing large datasets relevant to quality and compliance.
- Coordinate with cross-functional teams to ensure completion of assigned projects.
- Update the team to new and ongoing developments in the regulations governing the formulation and reporting of safety events (ICSR, PSUR, DSUR etc)
- Perform review of regulatory intelligence items received from various other sources including Cortellis and Global Regulatory Policy (GRP) on a regular basis
- Perform regular follow-ups with SMEs as necessary to confirm resolution of updates made based on the reported regulatory intelligence
- Support senior team members in performing review of Post Market and Clinical Trial submissions

**EDUCATION AND EXPERIENCE REQUIRED**:

- Minimum 4 + year of experience in drug safety or clinical research domain
- Degree in Life Science/Pharma or Equivalents

**PREFERRED SKILLS**:

- 4+ year of experience in drug safety, clinical research domain
- Awareness of Safety database, Scientific coding browser: MedDRA, WHO etc
- In depth Knowledge and understanding of Drug Safety/Pharmacovigilance regulations with respect to pharmaceutical drugs and other related products
- Strong organizational, documentation, and interpersonal skills essential to interact with clients, management, peers and cross functional teams effectively.
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
- 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,

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