Drug Safety/sr. 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:                               Senior Drug Safety Associate

Location:                               Mysore

Function:                               Drug Safety

DESCRIPTION:

Senior 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 data entry for all subject information into EDC databases as required
• 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.
• Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
• Training and mentoring of Pharmacovigilance associates

EDUCATION AND EXPERIENCE REQUIRED:

• Minimum 3 years of relevant experience in drug safety or clinical research domain
• Degree in Life Science/Pharma or Equivalent

PREFERRED SKILLS:

• 2 + year of relevant 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.