Paridhi Dubey
Senior Post Market Surveillance Specialist
Bottmingen,Basel land
Summary
Dynamic pharmacist with over a decade of experience in post-market surveillance, pharmacovigilance, regulatory compliance, and clinical trial coordination and management. Holds a master’s degree in pharmacy and possesses expertise in managing adverse event data, submitting post-market surveillance documents, and ensuring adherence to global regulatory standards. A proactive team player skilled in cross-departmental collaboration to achieve strategic goals while consistently pursuing professional growth and knowledge enhancement. Committed to driving excellence in pharmaceutical practices through meticulous attention to detail and a strong focus on compliance.
Overview
10
10
years of professional experience
Work History
Senior Post Market Quality Specialist
Cochlear Limited
05.2021 - 07.2025
- Spearheaded the development and execution of MDR-compliant Post-Market Surveillance Plans and Reports (PMSP, PSUR, PMCFP, PMCFER), ensuring full regulatory alignment and audit readiness.
- Collaborated cross-functionally with Regulatory Affairs, Clinical, R&D, and Quality teams to integrate PMS insights into product lifecycle management and design improvements.
- Led early signal detection and trend analysis activities by using automated monitoring tool Tableau and OBIIEE and on time communication with the team.
- Coordinated global PMS activities across EU, US, and APAC regions, harmonizing complaint handling and vigilance reporting processes.
- Contributed to risk management reviews (ISO 14971) by providing real-world evidence and post-market data to support benefit-risk assessments.
- Developed and maintained KPI dashboards for PMS metrics, enabling data-driven decision-making and executive-level reporting.
Regulatory Affairs Coordinator / Vigilance Specialist
Cochlear AG, Basel
05.2017 - 06.2021
- Responsible for Medical Device Vigilance Reporting (MDV) to the National Competent Authorities (NCAs) in the EU and Ministries of Health in other EMEA countries.
- Responsible for preparation & delivery of Initial Incident Reports, Follow-Up Reports and Final Incident Report to National Competent Authorities.
- Review "Regional Reportable Assessment" performed by Headquarters office and ensure the relevant Vigilance reports are delivered timely.
- Assist the Investigation Team with regards to information requested by National Competent Authorities.
- Support Regulatory Affairs Specialist in product registration in EMEA, Creation and maintenance of data for regulatory requirements of EU and Non-EU countries.
- Maternity break 2013-02 – 2015-08
Trial Document Specialist
Global Clinical Trial Organization, Actelion Pharmaceuticals, Basel
08.2010 - 02.2013
- Managing all documentation aspects of multi-centric Phase II & III trials.
- Working closely with the clinical team for collection, quality control, pre-coding, maintenance, storage and archiving of all Trial Master File (TMF) documents.
- Support the clinical teams in the preparation, conduct, and follow up of internal and/or external audits and inspections.
- Track and review TMF/eTMF (electronic TMF) documents for completeness, accuracy, and quality within required timelines while maintaining consistency and attention to details.
- Create, track, and resolve document quality issues and/or missing documents in CTMS system.
- Liaise with internal and regional teams to ensure document collection.
- Escalate issues that may impact the TMF/e TMF.
- Collaborated with cross-functional teams including clinical operations, regulatory affairs, and CROs to ensure timely and accurate document exchange.
- Trained and supported new staff on document management systems such as Veeva Vault and SharePoint, enhancing onboarding and system adoption.
- Played a key role in preparing regulatory submission packages, ensuring completeness and timely delivery.
Clinical Research Coordinator
Tata Memorial Hospital, Mumbai, India
04.2010 - 08.2011
- Responsible for the operational conduct and management of assigned clinical trial(s) in close collaboration with other functions Investigator, Study monitor and Ethics committees.
- Co-ordination and management of the Phase III Oncology trial, communication with sponsor and authorities.
- Responsible for the Trial documents submission to Ethics Committees and communication and tracking of approvals and Amendments.
- Recruitment and visit co-ordination of the trial subjects covering informed consent, screening and enrolment of the patient in Trial.
- Maintain and track records of study activity including case report form, drug dispensation record, regulatory forms.
- Accurate and timely collected data in electronic CRF
- Record Adverse event and side effect data and confer with investigators regarding the reporting of event to oversight agencies.
- Maintain contact with sponsors to schedule & coordinate monitoring visits and resolve queries.
- Maintain Investigator Site File.
Education
ICH GCP Online course -
Udemy
Certificate - Concept to CE Marking - including an update on the EU MDR
The Medical Device Summer School From Concept To CE Marking
Clinical Trial Management Course - undefined
CTC, Basel
Basics of European Regulatory Affairs - undefined
TOPRA
Quality Management in Clinical Research - undefined
Clinical Trial Unit, University Basel
Master’s - pharmacy
Narsee Monjee Institute of Management Studies (NMIMS)
04.2010
Bachelor’s - pharmacy
Shri Ram Institute of Technology (SRIT)
06.2007
Skills
- 2017/745 Medical Device Regulations
- Post Market Surveillance (Writing and Submission of PMS documents like PSUR, PMCF Plan and PMCF report)
- Regulatory Affairs, Vigilance Reporting
- Clinical Trials, Drug development process, ICH-GCP guidelines
- Trial Master File Management /Coordination
Languages
English Fluent
Hindi Mother Tongue
German A2
Work Type
Full TimeWork Location
On-SiteRemoteHybridTimeline
Senior Post Market Quality Specialist
Cochlear Limited
05.2021 - 07.2025
Regulatory Affairs Coordinator / Vigilance Specialist
Cochlear AG, Basel
05.2017 - 06.2021
Trial Document Specialist
Global Clinical Trial Organization, Actelion Pharmaceuticals, Basel
08.2010 - 02.2013
Clinical Research Coordinator
Tata Memorial Hospital, Mumbai, India
04.2010 - 08.2011
Clinical Trial Management Course - undefined
CTC, Basel
Basics of European Regulatory Affairs - undefined
TOPRA
Quality Management in Clinical Research - undefined
Clinical Trial Unit, University Basel
ICH GCP Online course -
Udemy
Certificate - Concept to CE Marking - including an update on the EU MDR
The Medical Device Summer School From Concept To CE Marking
Master’s - pharmacy
Narsee Monjee Institute of Management Studies (NMIMS)
Bachelor’s - pharmacy
Shri Ram Institute of Technology (SRIT)
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