Tanushree Siddhapathaki Email & Phone Number

Boston, Massachusetts, United States

Co-ordinated audits/inspections, tracked and analyzed key metrics, ensuring timely submissions of PSUR/DSUR, CAPAs, Labeling Deviations & and commitments, proficiently managing documentation requests and streamlining regulatory processes.Utilized MEDIVA, TrackWise and POWER-BI tools to effectively oversee and implement CMC and change control procedures.Oversaw and managed the communication flow of Regulatory Notifications with Global Health Authorities, ensuring compliance.Conducted interviews with LOCs to identify compliance challenges, developed innovative solutions and mitigation strategies, and successfully integrated change controls into Global SOPs.

Pune, Maharashtra, India

Mentored and guided a team of 10, imparting expert knowledge on ICSR case processing with different and enforcing compliance with stringent regulatory timelines.Managed end-to-end processing of Product Quality Complaint cases, cultivating a deep understanding of PSUR, DSUR, Annual Reports, and regulatory submission timelines across pre- and post-marketing phases.Spearheaded continuous improvement initiatives in case processing methodologies, resulting in enhanced efficiency and compliance. Received a 'Achieving Excellence Award' for contributions to the COVID-19 vaccination project.

Pune, Maharashtra, India

My responsibilities included:Orchestrated the efficient triage, intake, processing, and reporting of over 2000 ICSRs, ensuring adherence to regulatory global standards for JNJ Covid-19 Vaccine & other medicinal & consumer product pharmacovigilance. Demonstrated proficiency in utilizing Drug safety databases like ARIS Global & Argus Oracle ensuring accurate streamlined data management. Acquired and effectively applied a comprehensive understanding of MedDRA Coding principles.Executed flawless case management for various ICSRs (spontaneous, clinical study, legal & literature, SUSAR), led comprehensive due diligence activities for reporting, ensuring meticulous compliance with global regulatory mandates.

Pune, Maharashtra, India

• Maintained Batch Manufacturing records (BMR), storage release and Batch Packing Records for sterile dosage forms according to GMP.• Performed GMP compliance tasks including audits and document maintenance.• Maintained labelling and packaging of containers according to Good Manufacturing Practices (GMP).

Master'S Degree, Drug Regulatory Affairs, 4.00/4.00

learning about Drug regulatory complaints, FDA guidelines, product development Lifecycle and Management, Regulatory submissions, GxPs.

Bachelor Of Pharmacy - Bpharm, Pharmacy, 3.8/4.0

learned about Pharmaceutical chemistry, Pharmaceutics, Pharmacology, ADME profiles, Biopharmaceutics, Cosmeceutics, Pharmacovigilance.