Clinical Safety Specialist
Clinical Safety Specialist
Posted on :
29-01-2025
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1 Vacancy
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Job Description
Job Title: Clinical Safety Specialist
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique accessible and highquality medications Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust latestage pipeline. The company’s patientcentric products span the cardiovascular neurology endocrinology gastrointestinal institutional and orphan markets and have benefited millions of patients. For more information visit
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication integrity and creative spirit needed to thrive in our organization.
Brief Team/department Description
The Drug Safety team within Medical Affairs plays a critical role in ensuring the safety and wellbeing of patients by monitoring evaluating and reporting adverse events across all stages of a product’s lifecycle. This team collaborates closely with crossfunctional partners including Regulatory Affairs Clinical Development and Quality to ensure compliance with global pharmacovigilance regulations and maintain the highest standards of patient safety.
The Clinical Safety Specialist is an integral member of the team. The Drug Safety Clinical Specialist will be responsible for evaluating and managing clinical safety data to ensure the safety and wellbeing of patients throughout the drug development and postmarketing processes. This position will focus on analyzing adverse events (AEs) and ensuring compliance with regulatory requirements. The role involves collaborating with crossfunctional teams to assess the riskbenefit profile of products and contribute to pharmacovigilance activities. This position requires a detailed understanding of clinical trial processes drug safety regulations and clinical data management.
Principle Responsibilities
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication integrity and creative spirit needed to thrive in our organization.
Brief Team/department Description
The Drug Safety team within Medical Affairs plays a critical role in ensuring the safety and wellbeing of patients by monitoring evaluating and reporting adverse events across all stages of a product’s lifecycle. This team collaborates closely with crossfunctional partners including Regulatory Affairs Clinical Development and Quality to ensure compliance with global pharmacovigilance regulations and maintain the highest standards of patient safety.
The Clinical Safety Specialist is an integral member of the team. The Drug Safety Clinical Specialist will be responsible for evaluating and managing clinical safety data to ensure the safety and wellbeing of patients throughout the drug development and postmarketing processes. This position will focus on analyzing adverse events (AEs) and ensuring compliance with regulatory requirements. The role involves collaborating with crossfunctional teams to assess the riskbenefit profile of products and contribute to pharmacovigilance activities. This position requires a detailed understanding of clinical trial processes drug safety regulations and clinical data management.
Principle Responsibilities
- Review and assess adverse event (AE) reports from clinical trials postmarket surveillance and spontaneous/literature reports.
- Ensure timely and accurate reporting of serious adverse events (SAEs) to regulatory authorities including the FDA EMA and other relevant bodies.
- Assist in preparation and review of clinical safety documents including Safety Management Plans (SMPs) Clinical Safety Reports (CSR) clinical protocols and other required regulatory clinical safety reports.
- Ensure compliance with national and international pharmacovigilance regulations including GxP ICH guidelines FDA EMA and local regulatory bodies.
- Participate in audits and inspections by regulatory authorities or internal audit teams related to drug safety and pharmacovigilance activities.
- Collaborate with clinical research teams to assess clinical trial safety data identify adverse events of special interest (AESIs) and ensure timely reporting to regulatory authorities.
- Support the preparation of safetyrelated sections in clinical trial protocols and support business development clinical safety reviews.
- Assist in the design and execution of safety surveillance strategies for clinical trials including interim safety analyses and risk assessments to ensure that there are no gaps between clinical and safety teams.
- Bachelor’s degree in Life Sciences Pharmacy Nursing Medicine or a related field. Advanced degrees (MS PhD PharmD) are a plus
- 3 years of experience in pharmacovigilance drug safety clinical research or a related field.
- Knowledge of clinical trial processes regulatory guidelines and pharmacovigilance practices.
- Experience in adverse event reporting case processing and regulatory submissions including 505B2.
- Strong analytical skills with the ability to review analyze and interpret clinical safety data.
- Proficiency in pharmacovigilance software systems (e.g. Argus MedDRA etc).
- Excellent written and verbal communication skills with the ability to interact with regulatory authorities clinical teams and external stakeholders.
- Ability to work collaboratively in crossfunctional teams and communicate effectively with diverse stakeholders.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time
- While performing the duties of this job the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard operate a telephone and handheld devices
- Other miscellaneous job duties as required
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Employment Type
Full Time
Key Skills
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