Pharmacovigilance Analyst Clariwell Global

0.0 - 4.0 years

0 Lacs

nagpur, maharashtra

On-site

As a Safety Specialist, your primary responsibility will be to receive, triage, and process individual case safety reports (ICSRs) in a timely manner. You will accurately enter event data into PV databases and code medical terms using MedDRA / WHO-DD codes. It will be your duty to assess the seriousness, causality, and expectedness of cases, as well as conduct literature surveillance to identify potential safety signals. Additionally, you will play a key role in assisting with the preparation of case narratives, reports, and documentation. You will support the creation of aggregate safety reports such as PSURs and RMPs. Ensuring strict adherence to SOPs and regulatory standards will be crucial in this role. To qualify for this position, you should hold a Bachelors or Masters degree in Pharmacy, Life Sciences, Biotechnology, or a related field. You must possess excellent attention to detail and analytical capabilities. A basic understanding of medical terminology and drug safety processes is also required. This is a full-time, permanent position suitable for both experienced professionals and freshers. The work location will be in person, and benefits include health insurance, paid sick time, and paid time off.,

Posted 21 hours ago

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Pharmacovigilance Audit and Inspection Readiness Expert Opella

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As a Pharmacovigilance Audit and Inspection Readiness Expert at Opella in Hyderabad, you will play a vital role in ensuring the ongoing preparedness and readiness of Pharmacovigilance (PV) Operations for regulatory inspections and audits. Your responsibilities will include actively participating in inspection preparedness, organizing support for quality audits, and following up on audit findings through to closure. You will collaborate with global teams, manage CAPAs related to audits and inspections, and track deviations to ensure timely resolution. In this role, you will prepare for PV inspections from an operational perspective, facilitate responses to audit findings, and conduct mock inspections as required. Your expertise in PV databases like ARGUS and VAULT Safety, along with a minimum of 6 years of overall experience in the pharmaceutical industry with a focus on PV audits and inspections, will be crucial. You will oversee vendors, ensure compliance with safety regulations, and manage CAPAs effectively. Your soft skills will be put to use in stakeholder management, communication, and problem-solving. Attention to detail, analytical thinking, and strong project management abilities will be essential. You will need to demonstrate excellent teamwork, interpersonal skills, and the ability to work across functions in a multicultural environment. Your technical skills should include in-depth knowledge of global PV regulations, safety reporting requirements, GxP guidelines, and database management. Ideally, you will hold a Bachelor's degree in pharmacy or life sciences with a minimum of 3 years of experience in global PV audits, inspections, CAPA management, and risk analysis. At Opella, you will have the opportunity to work on challenging projects, develop consumer brands, and contribute to a collaborative and inclusive culture where personal growth and creativity are encouraged. Join us in our mission to make self-care simple and bring health into people's hands. Be part of a team that values honesty, courage, accountability, and simplicity. Together, we can drive sustainable impact and thrive in a culture that fosters innovation and excellence. Visit www.opella.com/en/careers to explore opportunities and be a part of our journey towards healthier people and planet.,

Posted 1 week ago

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