Pharmacovigilance Services Analyst Accenture

2.0 - 6.0 years

0 Lacs

chennai, tamil nadu

On-site

As a Pharmacovigilance Services Analyst at Accenture, you will be responsible for providing Pharmacovigilance & Drug Safety Surveillance services. With 2 to 5 years of experience and educational qualifications in Any Graduation/Bachelor of Pharmacy/Master of Pharmacy, you will play a key role in the management of the Affiliate Mailbox, reconciliation of reports, and performing follow-up attempts for both Serious and Non-serious cases. Your responsibilities will include case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and global regulatory requirements. In this position, you are expected to possess agility for quick learning, work effectively in a team setting, and demonstrate a strong commitment to quality. Proficiency in Japanese at an elementary level (JLPT N3 to N5) will be an added advantage. Your role will involve analyzing and solving lower-complexity problems, interacting with peers within Accenture, and receiving instructions on daily tasks from supervisors. While your decision-making will impact your work and potentially that of others, you will primarily focus on individual contributions within a team environment. Please be aware that this role may involve working in rotational shifts. Accenture, a global professional services company, offers expertise in digital, cloud, and security services across various industries. Within the Life Sciences R&D vertical, our services encompass research support, clinical trials, regulatory services, pharmacovigilance, and patient solutions. By joining the Clinical, Pharmacovigilance & Regulatory sub-offering, you will contribute to assisting leading biopharma companies in realizing their vision and enhancing outcomes through patient-centric approaches. Your role will be crucial in facilitating the convergence of scientific expertise with insights into the patient experience. To learn more about Accenture and our services, please visit www.accenture.com.,

Posted 3 weeks ago

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Medical Review Senior Associate Scientist Amgen Technology Private Limited

1.0 - 4.0 years

1 - 4 Lacs

Hyderabad, Telangana, India

On-site

To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work

Posted 2 months ago

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