Mahendra Kardile
Dombivli
Summary
Highly motivated and results-driven medical professional with over 8+ years of experience in the field of aggregate report writing. Skilled in authoring PSUR, PADERs. Seeking a challenging role in a dynamic company where I can continue to grow my skills and make a meaningful impact.
Overview
8
8
years of professional experience
Work History
Assistant Manager - Medical Writing
Alkem Laboratories Ltd., Mumbai
08.2021 - Current
- Authoring of variety of aggregate reports for global regulatory submissions that include but not limited to: Ensure compliance of operations and adhere to established regulatory standards
- To update and maintain aggregate report calendar
- To check and confirm the receipt of the entire source data
- Collate all the safety issue from previous reports, Health Authority assessment reports and new safety issues (all as applicable) identified by medical reviewer
- Key responsibilities: Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER) Quality Review of aggregate reports including PSURs, PBRERs, PADERs & ASRs Preparation of Risk Management Plan (RMP) for ROW
- Generating eCTD files from Dossier Management System for submission
- Preparation of documents as per eCTD and PDF specifications
- To mentor the new associates and conducting the training sessions for them
- Submission of ICSRs through B2B from Oracle Argus Safety.
Aggregate Report Writing Specialist
Fidelity Health Services
04.2017 - 08.2021
- Preparation of aggregate reports - PSURs and PADERs
- Retrieving of line listings from ArisG, Argus database
- Involved in submission of periodic reports to regulatory authorities within stipulated time frames
- Involved in database migration
- Involved in audit preparedness and faced external and internal audits
- Perform case book in, triage, data entry, coding and narrative writing after determination of the report as an initial case or follow-up report to an already existing case in database
- Processing of ICSRs from various sources such as spontaneous and clinical trials
- Performing literature screening, triaging and sending cases to service provider.
Drug Safety Executive
Ipca Laboratories Ltd.
11.2015 - 04.2017
- Authoring of variety of aggregate reports for global regulatory submissions that include but not limited to: Ensure compliance of operations and adhere to established regulatory standards
- To update and maintain aggregate report calendar
- To check and confirm the receipt of the entire source data
- Collate all the safety issue from previous reports, Health Authority assessment reports and new safety issues (all as applicable) identified by medical reviewer
- Key responsibilities: Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER) Quality Review of aggregate reports including PSURs, PBRERs, PADERs & ASRs Preparation of Risk Management Plan (RMP) for ROW
- Generating eCTD files from Dossier Management System for submission
- Preparation of documents as per eCTD and PDF specifications
- To mentor the new associates and conducting the training sessions for them
- Submission of ICSRs through B2B from Oracle Argus Safety.
Education
M.Pharm (Pharmacology) -
R.C.P.I.P.E.R, Shirpur (NMU, Jalgaon)
01.2015
Bachelor of Pharmacy, First class (63%) -
MIT, Pune (University of Pune)
01.2013
Skills
- Proficient with the use of Windows, MS Office, MS Outlook & Internet
- Ability to work within regulatory timelines and adhere to the protocols
- Good inter-personal and communication skills
- Strengths: Self-motivated, positive attitude, good listener, active team player
Qualification
M. Pharm (Pharmacology)
Languages
- Marathi
- English
- Hindi
Permanent Address
At & Post: Jakhangaon, Tal & Dist: Ahmednagar, Maharashtra, 414103
Personal Information
- Title: Medical Writer (Aggregate Reports)
- Date of Birth: 1991-08-10
- Nationality: Indian
- Marital Status: Married
Publications
Mahendra Kardile, Haidarali M Shaikh, Umesh Mahajan, Sameer N Goyal, Chandragouda Patil "Homeopathic drug standardization through biological evaluations: An untrodden avenue" International Journal of High Dilution Research 2015; 14(4):16-37
Projects
Anti-inflammatory activity of Ultra-high Dilutions of Homeopathic Drugs: In Vitro Evidences
Timeline
Assistant Manager - Medical Writing
Alkem Laboratories Ltd., Mumbai
08.2021 - Current
Aggregate Report Writing Specialist
Fidelity Health Services
04.2017 - 08.2021
Drug Safety Executive
Ipca Laboratories Ltd.
11.2015 - 04.2017
M.Pharm (Pharmacology) -
R.C.P.I.P.E.R, Shirpur (NMU, Jalgaon)
Bachelor of Pharmacy, First class (63%) -
MIT, Pune (University of Pune)