Highlights:

Skills:risk management plan, clinical study report, pharmacovigilance, PSUR, DSUR, clinical study protocol, CTD summary modules

Senior regulatory writer- Global drug development 11/2017 - current
Novartis healthcare Limited, Hyderabad, Telangana India
Industry: Pharmaceutical, biotech
working as a senior regulatory writer in Novartis since 2017. Working as a lead medical writer for various documents such as CSR, RMP, IB, DSUR, and CTD modules.
Senior regulatory writer for various documents such as risk management plans, DSURs, clinical study reports, CTD module 2 summary documents, Investigators brochure. o To author high quality regulatory documents: Clinical study reports, Module 2 summaries, risk management plans, DSURs, investigator’s brochure, safety reports, briefing books. o Act as the Lead Writer for assigned projects, lead document-related meetings, review statistical analysis plans, participate in submission strategy meeting. Participate in planning of data analyses and presentation to be used in documents. o Maintain oversight of projects, overall project management and collaborate with cross-functional teams for development and finalization of regulatory documents. o Peer review of reports authored by team members and review of reports that are outsourced to vendors. o As a RMP lead, work with team for projection of workload, assist in assigning resources for the project. o Coaching and mentoring of new team members joined in the team o Training of internal as well as external members involved in regulatory writing.--
Assistant Manager- Safety evaluation & risk management (Pharmacovigilance) 04/2015 - 11/2017
Glenmark Pharmaceuticals limited, Mumbai, Maharashtra India
Industry: Pharmaceutical, biotech
Worked as a safety scientist in a major Indian pharmaceutical company. Worked on various aspects of pharmacovigilance and drug safety.
Safety writer for pharmacovigilance deliverables; execution role. Authoring aggregate safety reports (PBRER, PSUR, DSUR, PADER) and risk management plans for investigational and marketed medicinal products. It included ownership of complete tasks associated with the aggregate reports such as request for inputs, analyzing and collating information, preparation of report, get it reviewed and work with regulatory affairs team for further submission. Peer review of reports authored by team members and review of the reports that outsourced to vendors. Review of relevant safety sections of CSR, investigators brochure, protocol and other clinical trial related documents. Literature search as defined in SOP to identify and analyze individual case safety report (ICSR), potentially relevant safety and efficacy information. Also involves interface with vendor/CRO for ICSR processing. Quality review and feedback on ICSRs processed by case processing group Active involvement in continuous implementation and up-gradation of relevant SOPs in liaison with QA--
Associate scientist- Clinical devvelopment 04/2012 - 03/2015
Lupin Limited, Pune, Maharashtra India
Industry: Pharmaceutical, biotech
Medical writer for NCEs and Biosimilars- Execution role. Role involved preparation of regulatory and other supporting documents for NCEs as well as biosimilars.
Medical writing i.e., preparation of investigator’s brochure, clinical trial protocols, informed consent forms, patient information sheet, subject diary, medical monitoring plan, clinical study report etc. Participate in clinical development strategy meetings for NCEs & biosimilars entering the clinic – Review of protocols and other documents of the studies outsourced to CROs. Actively participate in review of clinical documents such as Statistical analysis plans, CRF, statistical reports, safety narratives, appendices for clinical study reports. etc. Preparation of Clinical Development Plan Coordinating with internal team members for completion of assigned tasks Active involvement in continuous implementation and up-gradation of relevant SOPs in liaison with QA Preparation of responses to regulatory and EC queries.--
Senior executive- Clinical development and medical affairs 07/2008 - 04/2012
Piramal healthcare limited, Mumbai, Maharashtra India
Industry: Pharmaceutical, biotech
Medical writer for NCEs- Execution role. Role involved literature search, preparation of regulatory and other supporting documents for NCEs.
Writing documents such as CSR, ICF, Protocol, Investigator’s brochure for regulatory submissions. Written SOPs for Medical and scientific affairs function Assist in writing Clinical Development Plans Literature search, making presentations of study documents Registration of trials on clinical trial registries.--

Maharashtra animal and fishery sciences university Nagpur 10/2003 - 07/2008
Parbhani, Maharashtra, India
Degree: Bachelor's Degree
Major:Veterinary medicine, animal husbandary
Minor:Animal sciences
I am a veterinary physician by training. Completed Bachelors in veterinary sciences and animal husbandry (BVSc and AH), a 5 year degree course from Maharashtra animal and fishery sciences university, India.

Ashish Medical writing, regulatory writing, pharmacovigilance, RMP, CSR, IB