Mark P. Bercy
Boston,MA
Summary
I am a seasoned Pharmacovigilance/Drug Safety Operations professional with 17 years of industry experience. Throughout my career, I have effectively managed many safety vendors, internal safety teams, and worked to refine PV systems to ensure the highest level of safety compliance for PV organizations within both post-marketing and clinical spaces. My expertise is predicated on implementing new and improved PV procedures operationally, cultivating collaborative environments, and ensuring transparency cross-functionally within the company and with external parties.
Overview
18
18
years of professional experience
Work History
Associate Director, Drug Safety Operations
Kura Oncology
01.2023 - 10.2024
- Oversee and contribute to work performed by the PV/Safety vendor, including establishing Key Performance Indicators (KPIs), in monitoring all work performed by the PV vendor for the Drug Safety function
- Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor
- Ensure safety reports received from clinical trials are processed in a consistent and fully compliant manner
- Oversee SAE/SUSAR reporting activities for all investigational drugs (maintain oversight to ensure global clinical trials case reporting process is efficient and compliant with worldwide reporting requirements)
- Assist with the preparation, and review of, drug safety aggregate reports such as DSURs
- Assist with projects and initiatives, including but not limited to, audit/inspection readiness, SDEAs/PVAs with business partners, and represent PV in collaboration with other functions, as needed
- Assist with the creation and/or review of MSAs, SOWs, invoices and payment of work performed by PV vendor
- Assist in the creation and approval of PV SOPs and Work Instructions
- Oversee deviation and CAPA activities in relation to, but not limited to, external quality events at the safety vendor, late SUSAR or aggregate report submissions, and case management processes as defined per the SMPs or SOPs
Sr. Manager, Pharmacovigilance
Novo Nordisk/Dicerna Pharmaceuticals
12.2018 - 01.2023
- Vendor oversight of safety vendor performing PV operations activities (safety database hosting/mgmt., case processing, safety submissions, aggregate reports, eTMF filing) through daily surveillance, weekly update meetings, and quarterly governance meetings
- Oversight by way of performance and compliance monitoring, safety data quality checks, query management, deviation management, and process improvements
- Serve as the point of contact and intermediary for collaborations between internal functions and safety vendor
- Monitor activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans and other contractual agreements
- Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and safety signal management
- Create processes and procedural documents (SOPs, job aids, conventions) relating to PV activities
- Participate in cross-functional team meetings and safety oversight meetings that contribute to managing overall benefit/risk profile of a given compound
- Oversee drafting and submission of aggregate safety reports such as Development Safety Update Reports (DSURs) and Six-Monthly Line Listings (6MLLs) in collaboration with external safety vendor
- Spearhead high level safety governance activities and communicate potential clinical and nonclinical safety issues across critical company functions
- Collaborate with Medical Director and CMO, as well as Clinical Development Operations and vendor clinical staff who provide medical and/or monitoring support for ongoing clinical trials
Drug Safety Consultant
Merrimack Pharmaceuticals
09.2018 - 12.2018
- Receive, process, and report clinical trial adverse events, including coordinating and ensuring submissions to the appropriate authorities and/or agencies
- Perform quality checks on adverse events processed by various CROs
- Generate systems reports and Advanced Conditions using the Argus safety database (also have ARISg experience)
- Creating processes and procedural documents (SOPs, job aids, conventions) relating to operational activities
Senior Manager, PV Operations
ARIAD Pharmaceuticals, Inc.
01.2012 - 11.2017
- Effectively lead and manage internal Clinical and Post-marketing PV Operations teams and external third-party vendors responsible for performing various global PV activities
- Responsible for oversight of both serious and non-serious adverse events in oncology clinical trials and with commercial products, which is globally available, focusing on the evaluation and reporting of individual case safety reports in accordance with global safety regulations, departmental standard operating procedures and company policies
- Striving to achieve safety data quality and compliance with completion of related PV activities (regulatory reporting, reconciliation activities, process documents updates/improvements, trainings, projects, etc.)
- Track and manage ICSRs of all report types (clinical trial, post-marketing, literature, ISTs) from receipt to closure, perform verification of safety data and will utilize clinical/pharmacovigilance judgment in coding of adverse events and construction of accurate and complete narratives
- Creating processes and training internal and external parties on procedural documents (SOPs, job aids, data and coding conventions) relating to operational activities
Global Patient Safety Specialist
Genzyme Corp. / Sanofi
01.2009 - 01.2012
- Receive, process, and report adverse events, to the appropriate authorities and/or agencies
- This includes ensuring all reporting paperwork is complete, following up on incomplete information, and recording the receipt of information in the appropriate databases
Drug Safety Associate II
EMD Serono
01.2007 - 01.2009
- Receive, collect, and document accurate information on potential adverse event reports reported by consumers, HCPs, other manufacturers, call centers, and other EMD Serono staff
- Processing assigned ICSRs in ARISg (data entry, quality review, reporting)
Education
Bachelor of Arts - Psychology
Brandeis University
Waltham, MASkills
- Twelve years of vendor oversight experience in Manager, Sr Manager, and Associate Director roles
- Primary or secondary author (drafting, updating, finalization, and training) of various procedural documents (SOPs, job aids, SMPs, Data Entry Conventions, MedDRA Coding Conventions)
- Managed authoring/updates of company Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) ensuring contractual obligations are mutually understood and achieved and to satisfy operational/regulatory requirements
- Primary point of contact (POC)/subject matter expert (SME) with external partners and vendors
- Broad range of experience within different therapeutic areas (Oncology, Transplant, Renal, Rare Disease, Neurology)
- Actively participated in data migration projects following company acquisitions
- Experience in operating both postmarketing and clinical safety operations
Accomplishments
- Maintained greater than 97% compliance annually with regulatory submissions (as Specialist and as Manager)
- Spearheaded successful and timely completions of data cleanups/migrations and other PV projects
- Regulatory inspection and PV audit preparation and execution
Timeline
Associate Director, Drug Safety Operations
Kura Oncology
01.2023 - 10.2024
Sr. Manager, Pharmacovigilance
Novo Nordisk/Dicerna Pharmaceuticals
12.2018 - 01.2023
Drug Safety Consultant
Merrimack Pharmaceuticals
09.2018 - 12.2018
Senior Manager, PV Operations
ARIAD Pharmaceuticals, Inc.
01.2012 - 11.2017
Global Patient Safety Specialist
Genzyme Corp. / Sanofi
01.2009 - 01.2012
Drug Safety Associate II
EMD Serono
01.2007 - 01.2009
Bachelor of Arts - Psychology
Brandeis University
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