Sameer Sanjay Apte
Pune
Summary
Dynamic Medical Manager with extensive experience at Pfizer India Products, specializing in pharmacovigilance and regulatory compliance. Resourceful Medical Manager known for high productivity and efficient task completion. Specialize in healthcare administration, operational analysis, and regulatory compliance. Excel in communication, leadership, and problem-solving to enhance team performance and patient care outcomes. Detail-oriented Medical and Health Services Manager passionate about facilitating excellent patient care. Adept at designing and implementing policies and procedures. Motivated team builder and supervisor focused on driving team collaboration.
Overview
19
19
years of professional experience
Work History
Medical Manager
Pfizer India Products
09.2023 - Current
- Analyzed post-market surveillance data and clinical literature for risk assessment at Pfizer.
- Conducted comprehensive literature searches to identify important safety information.
- Reviewed harms lists from Global Medical and Safety Lead, integrating insights from adverse event data.
- Recommended severity scores and assigned risk categories based on detailed data analysis.
- Provided MedDRA preferred terms related to complaint subclasses for identified harms.
- Developed a reference binder documenting sources used in the Medical Rationale Document.
- Created and updated Clinical Evaluation Reports and Plans as necessary.
- Led cross-functional teams to ensure effective implementation of clinical trial protocols.
Sr. Scientific and Medical Writer Grade III / Assistant Manager
SpringerNature / Wipro Limited
Pune
12.2014 - 09.2023
- Conducted literature surveillance activities in compliance with regulations and established processes.
- Developed clear and concise scientific documents for medical publications.
- Screened published literature reports to identify Individual Case Safety Reports (ICSRs).
- Triaged safety search results for potential ICSRs based on customer-defined signal detection criteria.
- Segregated non-ICSRs from literature articles, conducted case reviews, and authored narratives.
- Performed causality assessments using information from relevant articles.
- Participated in audits, validating EMA-MLM articles, and supported regulatory inspection preparations.
- Developed search strategies utilizing OVID, Embase, and PubMed to fulfill safety literature requirements.
- Authored concise summaries capturing key elements for PADERs, PSURs, and related reports.
Data Analyst – Pharmacovigilance
Cognizant Technologies Solutions Private Limited
Mumbai
06.2014 - 12.2014
- Managed entire gamut of activities related to primary review of cases, data entry, coding of events, medical conditions and medications.
- Led and executed labeling of events and generating follow-up information.
- Conducted quality checks on the cases completed by case processors as assigned and validated accuracy of documentation.
- Scrupulously maintained 100% book-in, data entry and triaging of all cases in safety database as per agreed timelines.
- Ensured that all teams complete assigned trainings within timeline and kept the track of the same. Mentored new hires and trainees.
Safety Data Analyst
Sciformix Technologies Private Limited
Pune
07.2013 - 06.2014
- Executed project management activities with proper case allocation to 35 physicians across India, USA, and Manila.
- Tracked individual case safety reports within the database to ensure accuracy.
- Formulated and published daily, weekly, and monthly productivity and quality metrics.
- Generated monthly billing data for client verification and invoicing.
- Extended support to lead physicians for operational data generation as needed.
- Implemented efficient processes to meet timelines and standard operating procedures.
- Ensured compliance with all governing regulatory requirements during operations.
- Analyzed safety data trends to identify potential risks in clinical trials.
Safety Associate II
InVentiv International (Pharmanet-i3) Healthcare Private Limited
Pune
09.2012 - 06.2013
- Reviewed serious adverse experience information received from investigator sites and AE from post marketing sources for completeness and regulatory compliances.
- Delivered input for and reviewed relevant safety tracking systems for accuracy & quality.
- Formulated safety data reports for submissions to client.
- Extended support in representing Global Safety and Pharmacovigilance group at project team and client meetings.
- Interacted with clinical operations and clients to ensure compliance with safety and Pharmacovigilance SOP’s.
Safety Data Analyst
Sciformix Technologies Pvt. Ltd.
Pune
10.2010 - 09.2012
- Triaged Spontaneous and Literature cases using AERS database.
- Ensured that project specific Safety mail boxes, fax machines are checked daily for ICSRs.
- Identified ICSRs requiring expedited reporting according to applicable requirements.
- Segregated cases from Reaction Weekly/Ovid alerts in valid, invalid and ALC (Abbreviated Listed cases) and process ALC’s using Argus database.
- Performed data entry of Literature as well as MHRA cases or ASPR (Anonymized Single Patient Report) using AERS database.
Auditor
RGIS Limited
London/Glasgow
10.2010 - 09.2010
- Audited the stock and prepared stock reports.
- Maintained stock at Pharmacy.
Executive - SMART
Emcure Pharmaceuticals Limited
Pune
10.2006 - 08.2007
- Monitored comparative bioequivalence studies for adherence to protocols and regulatory standards.
- Coordinated with Investigators and CRAs to resolve emerging issues promptly.
- Participated in Ethics Submissions (IRB) alongside Clinical Research Organization for compliance assurance.
- Led cross-functional teams in executing strategic initiatives within pharmaceutical operations.
- Facilitated internal communications to improve team collaboration and information exchange.
Education
Master of Science - Pharmacology & Toxicology
Glasgow Caledonian University
United Kingdom11-2008
Bachelor of Pharmacy -
University of Pune
India05-2005
Skills
- Pharmacovigilance and drug safety
- Regulatory compliance
- Data analysis and signal detection
- Medical writing and literature review
- Clinical research management
- MS Excel and Office proficiency
- Audit management and quality assurance
- Risk management strategies
- Standard operating procedures (SOPs)
- Organizational skills and record keeping
- Medical device regulations (MDR)
- Data analysis with SQL and Python
- Project management tools (JIRA)
- Document handling with Endnote
- Documentation review
- Problem solving and clinical evaluation
Additional Information
Registered Pharmacist, Maharashtra State Pharmacy Council, India, Member, Indian Pharmaceutical Congress
Languages
Marathi
First Language
Hindi
Advanced (C1)
C1
English
Proficient (C2)
C2
Skills
Pharmacovigilance |Literature review| ICH-GCP |Regulatory affairs|MS Excel, EndNote|Audit management| Clinical Research | RMSR/RMP/HA/UTA/FMEA |Writing SOPs and WPDs|Quality assurance|Record keeping|Literature searches|Drug safety|Organizational skills, PSMF| Triage | SCAR | Contracts | CAPA |BA/BE studies| ISO 13485:2016 | ISO 14971:2019 |21 CFR 820| MDR 2017/745 |AAMI TIR 105|Medical affairs|Meddev 2.7.1 rev4|MDD 93/42/EEC| IEC 60601|
Databases and Programming
Argus, AERS, ArisG, MedDRA, WHO DD, Endnote, MS Office, JIRA, LINQ Pad, SQL (SSML and Oracle Apex) queries basic, Python 3 basic
Timeline
Medical Manager
Pfizer India Products
09.2023 - Current
Sr. Scientific and Medical Writer Grade III / Assistant Manager
SpringerNature / Wipro Limited
12.2014 - 09.2023
Data Analyst – Pharmacovigilance
Cognizant Technologies Solutions Private Limited
06.2014 - 12.2014
Safety Data Analyst
Sciformix Technologies Private Limited
07.2013 - 06.2014
Safety Associate II
InVentiv International (Pharmanet-i3) Healthcare Private Limited
09.2012 - 06.2013
Safety Data Analyst
Sciformix Technologies Pvt. Ltd.
10.2010 - 09.2012
Auditor
RGIS Limited
10.2010 - 09.2010
Executive - SMART
Emcure Pharmaceuticals Limited
10.2006 - 08.2007
Master of Science - Pharmacology & Toxicology
Glasgow Caledonian University
Bachelor of Pharmacy -
University of Pune
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