Mahima P.

Mahima P. has a diverse work experience in the field of pharmacovigilance and drug safety. Mahima is currently working as a Senior Manager- Drug Safety & Pharmacovigilance Compliance and Training at Sage Therapeutics since April 2021. Prior to this, they worked at AMAG Pharmaceuticals as a Manager- Pharmacovigilance Compliance from October 2018 to April 2021. Mahima played a key role in developing and aligning pharmacovigilance procedures, monitoring post-marketing commitments and responses to audit observations, and coordinating CAPA plans including training and documentation. Mahima also received recognition for developing interactive training materials and successfully completing the transition of a safety project.

Before AMAG Pharmaceuticals, Mahima worked as an Assistant Manager- Electronic Health Record (Epic/NexGen) at IKS Health from January 2015 to March 2017. In this role, they analyzed training needs and designed training programs, developed training materials, and converted operation-related materials into user-friendly training materials.

Prior to IKS Health, Mahima worked at Accenture as a Training and Quality Lead, Drug Safety Surveillance- Pharmacovigilance from May 2012 to August 2014. Mahima'sresponsibilities included leading a backroom in a USFDA inspection and designing and delivering training for new joiners.

Mahima started their career at Cognizant, where they worked as a Subject Matter Expert- Drug Safety Surveillance- Pharmacovigilance from September 2010 to May 2012. In this role, they performed quality control on various types of cases and maintained the schedule of aggregate reports for peer review. Mahima also worked as a Junior Data Analyst- Drug Safety Surveillance- Pharmacovigilance at Cognizant from September 2009 to September 2010, where they managed safety data and processed different types of cases.

Overall, Mahima P. has extensive experience in pharmacovigilance and drug safety, with a strong focus on compliance, training, quality control, and project management. Mahima has demonstrated their expertise in developing training materials, leading inspections, and ensuring the accuracy and consistency of safety data.

Mahima P. earned a Bachelor of Pharmacy (B.Pharm.) degree in Pharmacy, Pharmaceutical Sciences, and Administration from Bharati Vidyapeeth in the years 2003 to 2007. Following this, they pursued a Master of Science (M.Sc.) degree in Pharmacy, Pharmaceutical Sciences, and Administration from Kingston University from 2007 to 2008. In 2017, Mahima continued their education at Harrisburg University of Science and Technology, where they obtained a Master of Science (MS) degree in Project Management, which they completed in 2019.

Additionally, Mahima P. has acquired several certifications throughout their educational journey. Mahima obtained the "Certified MedDRA Coder" certification from Northrop Grummen in March 2011. In September 2015, they completed the "Train the Trainer" certification from IKS Health. In July 2018, Mahima furthered their knowledge with three certifications: "Instructional Design: Adult Learners" from Lynda.com, "How to Design and Deliver Training Programs" from LinkedIn, and "Instructional Design: Models of ID" also from Lynda.com.