Drug Safety Associate

2 weeks ago


Mysore, India Sitero LLC Full time

**DRUG SAFETY ASSOCIATE - JOB DESCRIPTION**

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: Drug Safety Associate (DSA)**

**Location: Mysore - Hybrid**

**Function: Drug Safety**

**DESCRIPTION**:
Drug Safety Associate is a safety professional responsible for assessing the safety of pharmaceutical drugs undergoing clinical trials or once they are in the market. Using standard guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to regulatory bodies and health authorities.

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, literature and any other relevant sources
- Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
- Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
- Responsible for identifying duplicate/invalid ICSRs
- Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports
- Perform peer review, quality review of cases as and when required
- Perform peer review, quality review of all EDC data entered as required
- Accountable for sending queries for clarity associated with incoming information if required
- Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., MedDRA, Company Product Dictionary, WHO-DD).
- Ensure that case narrative comprises correct and appropriate safety information
- Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
- 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 1+ year of experience in drug safety or clinical research domain
- Degree in Life Science/Pharma or Equivalents

**PREFERRED SKILLS**:

- 1+ 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, protected veteran status, disability, or any other factors prohibited by law.



  • Mysore, India Sitero LLC Full time

    **DRUG SAFETY ASSOCIATE TRAINEE- JOB DESCRIPTION** 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...

  • Drug Safety Scientist

    2 weeks ago


    Mysore, India Sitero LLC Full time

    **Drug Safety Scientist - JOB DESCRIPTION** 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...

  • Front Desk Associate

    3 weeks ago


    Mysore, Karnataka, India The Hosteller Full time

    Job role: Front desk manager/executive/associateLocation: South IndiaDepartment: Hotel operationsJob experience: 1-3 yearsJob briefA front desk manager/executive/associate shall be responsible for management of the company's backpacker hostels effectively. He/she shall be entrusted to effectively be a part of the managing team for a 35-50 keys hotel/hostel...


  • Mysore, Karnataka, India Raahgiri Foundation Full time

    Project Associate – Green Mobility Zone Implementation Organization: Raahgiri Foundation Location: Gurugram/ Mathura, UP Experience: 2+ years About the Role We are searching for a motivated and passionate Project Associate to join our team working on implementing road safety, green mobility and low emission zones towards healthy, vibrant liveable urban...


  • Mysore, India S3V vascular Technologies Full time

    Prepare, review, file, and support premarket documents for Indian and global registrations for assigned medical device projects. - Collaborate with intra and inter department personnel and support marketing authorizations for assigned projects. - Represent Regulatory Affairs as team member of product development projects from Concept through...


  • Mysore, Karnataka, India J. J. Keller & Associates, Inc Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    Requisition #: 20199Functional Area: Administrative Support; Human ResourcesEmployment Type: Full-TimeWork Options: In Office at Location Specified Above #LI-OnsiteWork Hours: 4:00 PM to 2:00 AM ISTAbout J. J. Keller IndiaSince we began as a family-owned company in 1953, our purpose at J. J. Keller & Associates, Inc. has been to protect people and the...


  • Mysore, Karnataka, India J. J. Keller & Associates, Inc. Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Requisition #:20199Functional Area:Administrative Support; Human ResourcesEmployment Type:Full-TimeWork Options:In Office at Location Specified AboveWork Hours:4:00 PM to 2:00 AM ISTAbout J. J. Keller IndiaSince we began as a family-owned company in 1953, our purpose at J. J. Keller & Associates, Inc. has been to protect people and the businesses they run....


  • Mysore, Karnataka, India Avani Consulting Full time ₹ 5,00,000 - ₹ 7,00,000 per year

    Hi, Greetings from Avani Consulting .We are hiring for the below opportunity:Company: A leading Pharmaceutical API UnitDesignation: Associate Engineering maintenance Process, WTPExperience: 3-5 year in API-PharmaceuticalQualification: Diploma / BE in Mechanical EngineeringDepartment: EngineeringLocation: MysorePackage 5-7 LakhRoles & Responsibility:Candidate...


  • Mysore, India Marriott Full time

    JOB SUMMARYManages the daily functions of the department to ensure protection of property assets employees guests and property Maintains logs certifications and documents required by law and Standard Operating Procedures Trains staff in established emergency procedures and implements accident and fire prevention procedures Position focuses on ensuring...


  • Mysore, India Life Educare Pvt. Ltd. Full time

    **JOB DESCRIPTION ADMINISTRATOR**: - The Administrator shall plan the academic or auxiliary activities of the school as per the guidance of the principal. - Management of, counsellors, administrative staff and administrative staff. - The maintenance of attendance records, personnel reports, planning and other activities. - To be responsible for the school...