Nirav P.

About Nirav P.

Holds a PharmD and Master’s in Health Science (Regulatory Affairs) from Fairleigh Dickinson University, with a strong foundation in regulatory compliance and medical terminology. Previous experience includes optimizing pharmacovigilance and cosmetovigilance processes and achieving a 95% compliance rate at Avet Pharmaceuticals and Taro Pharmaceuticals. Proficient in MedDRA coding, narrative writing, and pharmacovigilance audit preparation, supporting organizational excellence in drug safety.

Experience

1. Drug Safety Specialist

   SUN PHARMA

   Aug 2023 — Present · Hawthorne, NY, US

   Conduct medical assessment of literature, solicited, and unsolicited cases to ensure accurate evaluation and reporting of adverse events• Handled 1,500+ global cosmetovigilance cases annually, including adverse events, product quality complaints, and medical inquiries for cosmetic and topical OTC products across US, EU, and Canadian markets.• Implement CAPA processes that have successfully reduced late case reporting by 95%• Develop and implement procedures to regularly test and verify the functionality of communication channels used to receive adverse event reports from consumers• Establish and oversee pharmacovigilance audit processes for third-party vendors, ensuring compliance with regulatory standards• Provide expert medical assessment on adverse event cases, ensuring thorough and precise evaluation• Participated in regulatory affairs, including reviewing product monographs, drafting responses to pharmacovigilance requests from regulatory agencies, and supporting the development of pharmacovigilance contracts and agreements. Using systems like ARGUS for managing AE data, ensuring full alignment with international regulatory guidelines• Leading signal detection activities, reviewing cumulative AE trends from global sources, literature, and partner data to identify potential safety issues.• Collaborate with PV Physicians to assess safety signals and draft evaluation reports in line with Signal Management standards.• Draft and submit high-quality narratives (SAEs, special situations, SUSARs), ensuring accurate MedWatch/CIOMS forms for global submissions.• Perform end-to-end case processing in ARGUS: triage, coding, follow-up, submission.• Wrote and reviewed Global Risk Management Plans (RMP) and contributed to REMS planning for applicable products.• Authored and reviewed PSURs and DSURs for assigned product groups.• Led CAPA implementations that reduced late case submissions by 95%.

Education

• Fairleigh Dickinson University

  Doctor of Pharmacy - PharmD + Master in Health Science (Regulatory Affairs), Pharmacy

  2017 — 2021

• Gujarat University

  Bachelor of Pharmacy - BPharm, Pharmacy

  2008 — 2011