Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 2 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 2 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).

Job Title : Pharmacovigilance Specialist Location : Bangalore / Hyderabad Experience : Minimum 4 Years in PV ICSR Job Summary We are seeking a skilled and detail-oriented Pharmacovigilance (PV) Specialist with hands-on experience in Individual Case Safety Reports (ICSR) . The ideal candidate will be responsible for end-to-end case processing and ensuring compliance with global PV regulations and internal SOPs. Key Responsibilities : Perform case intake, triage, data entry, quality review, and submission of ICSRs. Evaluate and code adverse event reports using MedDRA and WHO-DD coding. Ensure timely reporting of adverse events to regulatory authorities and clients. Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO). Collaborate with cross-functional teams to ensure accurate and complete safety data. Contribute to audit and inspection readiness. Prepare periodic safety update reports (PSURs) and other regulatory documents when required. Qualifications : Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum 4 years of hands-on experience in PV ICSR processing. Strong understanding of global PV regulations and ICH-GCP guidelines. Familiarity with PV databases (e.g., Argus, ArisG) is an advantage. Excellent attention to detail and strong analytical skills. Good communication and documentation skills. Preferred Attributes : Certification in Pharmacovigilance will be an added advantage. Ability to work independently and as part of a team. Willingness to work in shifts if required (based on client/region).