Clinical Safety Contractor

1 month ago


Hyderabad, India NITZ Consulting Private limited Full time

**NITZ Consulting private Limited Inc. (“NItz”) **is committed to providing quality service in the field of pharmacovigilance to clients. Our clients range from mid-size to small pharmaceutical companies located worldwide who are engaged in developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematological malignancies.

The **Clinical Safety Contractor **will provide high-level support to Client and function by leading assigned developmental products, managing individual case safety reports (ICSR), and authoring aggregate safety reports. Prior experience and broad knowledge of pharmacovigilance/clinical safety, evaluation, and risk management is required. Work location: Remote

**Responsibilities**:

- Maintain understanding and ensure compliance with CS&RM SOPs and WPs, GCP, ICH guidelines, and applicable guidance documents/regulations (e.g., US FDA CFR and EU GVP) during the management of safety data received from company-sponsored and external partner studies.
- Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures.
- Track and identify potential safety signals and escalate to the medical review function.
- Gather and analyze safety data for escalation and possible presentation to the Executive Safety Advisory Committee
- Facilitate deliverables using strong project management/time management.
- Contribute to safety sections of investigator or regulator communications, Investigator brochure, and other reports.
- Participate in the set-up and maintenance of adverse event processes for global clinical trials.
- Perform Quality Review of the ICSRs, including reviewing data entered within the safety database against the source documents and ensuring a concise and medically relevant case narrative.
- Obtain clinically meaningful information from investigators to provide a robust safety assessment.
- Support the development of electronic case report forms, participate in the configuration of the clinical database for safety specifications, perform User Acceptance Testing, maintain documentation.
- Assist with periodic reconciliation of safety data between the department and other sources (i.e., recon between the safety and clinical databases)
- Act as a liaison internally and externally (e.g., Clinical Development, Regulatory Affairs, Biometrics, parent company, and business partners) to develop programs and processes.
- Support the development and maintenance of SOPs, WPs, and other applicable documentation.

**Qualifications**:

- Required: PharmD
- Clinical (patient care) experience is preferred.
- A minimum of 4 years’ experience in Clinical Drug Safety and/or Pharmacovigilance
- Ability to maintain an “inspection ready” environment.
- Ability to present, train, and/or explain processes to all levels of the organization.
- Demonstrated competency within a Safety Database such as Argus or ARISg
- Previous experience within an EDC system is desirable.
- Initiative, resourcefulness, accountability, and teamwork

Pay: The hourly rate range for this position is INR 2,00,000 per month.

**Job Types**: Temporary, Freelance
Contract length: 12 months

**Salary**: ₹150,000.00 - ₹200,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Internet reimbursement
- Work from home

Schedule:

- Night shift
- US shift

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

- Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- Master's (required)

**Experience**:

- total work: 4 years (required)

**Speak with the employer**
+91 8328127521



  • hyderabad, India Lifelancer Full time

    Job Summary: We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory...


  • hyderabad, India Novartis Full time

    Your responsibilities include, but are not limited to:May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): chip in to the development of...

  • Safety Case Expert

    1 month ago


    Hyderabad, Telangana, India Novartis Full time

    Your responsibilities include, but are not limited to: - Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents and product and event coding, narrative writing and follow-up for missing or other medical important information. Including daily...


  • Hyderabad, Telangana, India Thermo Fisher Scientific Full time

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...


  • Hyderabad, India Learning Labb Research Institute Full time

    As a Clinical Research Associate, you'll play a pivotal role in ensuring the successful execution of clinical trials. From monitoring trial progress to ensuring regulatory compliance and participant safety, you'll be at the forefront of cutting-edge medical research.Key Responsibilities:- Conduct site visits to monitor trial activities and ensure compliance...


  • Hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Hyderabad, India Novartis Full time

    “150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and...


  • hyderabad, India Seven Consultancy Full time

    JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee.2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.4) Liaise with ethics...


  • hyderabad, India Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • Hyderabad, India Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • hyderabad, India Seven Consultancy Full time

    JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee.2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.4) Liaise with ethics...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: “150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs...


  • hyderabad, India Seven Consultancy Full time

    JOB DETAILS 1. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice (GCP) guidelines, and other applicable regulatory requirements.2. Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP...

  • Principal Scientist

    1 week ago


    Hyderabad, Telangana, India Novartis Full time

    **Summary**: The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and...

  • Safety Specialist

    1 month ago


    Hyderabad, Telangana, India Thermo Fisher Scientific Full time

    Job DescriptionJob DescriptionPerforms day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Hyderabad, India Clarivate Full time

    We are looking for an Associate Content Editor to join our team in Hyderabad. This is an amazing opportunity to work on OFF-X, a translational drug safety intelligence portal. The team consists of 20 people located in Spain and India and is reporting to the Regulatory and drug safety manager line. We have a great skill set in the analysis of drug safety and...