Drug Safety Associate

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**:AR Specialist

**Location**:Mysore
- Hybrid

**Function**:Drug Safety Services

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, health authority responses), RMP/REMS and signal management 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
- Attend internal and technical team meetings as required.
- Training and mentoring of Pharmacovigilance associates.
- Miscellaneous:

- Maintain rigorous adherence to written procedures, e.g., SOPs/Work instructions
- Adherence to Company Health & Safety procedures
- Participate in refresher training programmes.
- Should archive all documents internally as per procedure.
- Should complete all trainings on or before due date in relevant training platforms.
Any other duties as assigned by your manager.
- **EDUCATION AND EXPERIENCE REQUIRED**:
Minimum 2 years of experience in authoring with at least 1 year of experience in Quality Review of Aggregate Reports- Degree in Life Science/Pharma or Equivalent

**PREFERRED SKILLS**:

- Preferred: 2 years of experience in authoring with 1 years of quality review of Aggregate Reports
- Knowledge of principles of epidemiology and statistics
- Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies.
- Good documentation practice
- Knowledge and information sharing
- Excellent attention to detail
- Proficient computer knowledge and computer keyboarding skills.
- Proficient with Microsoft Office Suite (Outlook, Word, Excel, PPT).
- Strong verbal, written and interpersonal communication skills.
- 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.
- Innovative, collaborative, initiative-taker.
- A solutions provider with strong multi-tasking abilities
- Manage evolving deadlines effectively with regular feedback and updates.