Community Spotlight

Clinical Safety and Pharmacovigilance Community
Engage, Inform, and Grow
Karen P. Ward
CSP Community Chair
Golden Gate Compliance, LLC

he DIA Clinical Safety and Pharmacovigilance Community offers a collaborative environment in which to promote industry best practices, generate new ideas, and discuss the impacts of the changing regulatory environment as it relates to Clinical Safety and Pharmacovigilance (CSP). Our efforts are intended to enhance the practice of monitoring the safety of drugs, biologics, and devices in the interest of public health.

The CSP Community recently welcomed Karen Ward as its new Chair, following Catherine Baldridge. Under Catherine’s leadership, the Community advanced its goals of establishing a core leadership team, increasing membership, and providing educational opportunities to its members. Over the past year, the Committee hosted training sessions on MHRA PV Inspections, Local Literature Monitoring, Local Qualified Person for Pharmacovigilance (QPPV), Signal Detection, Risk Evaluation and Mitigation Strategies (REMS), and the Pharmacovigilance System Master File (PSMF). Catherine will remain an active part of the Community focusing on Member Engagement as a leader on the CSP Core Team.

Community Membership

Our CSP Community membership consists of over 350 individuals representing healthcare and life sciences globally. Our members have a range of safety and pharmacovigilance experience and practice within academia, biotechnology, pharmaceuticals, contract research, government, law firms, and consulting organizations.

The Core Leadership Team assists the Community Chair in championing the mission of the Community. Our Core Leadership Team and their CSP Community responsibilities include Nicole Baker, Programing and Publication Liaison (Ireland), Catherine Baldridge, Member Engagement Coordinator (US), Reena Harjai, Program Coordinator (US), Mengchun Li, Cross-Functional PV/Statistics Leader (US), Jill Notte, Communications Coordinator (US), and Cristina Parau, Education Coordinator (UK).

CSP Community Goals for 2019

  1. Engage: Provide educational opportunities and a forum within DIA to disseminate information on global safety and pharmacovigilance issues. Collaboration with other DIA Communities (including Patient Engagement, Regulatory Affairs, Clinical Research, and Legal) will expand member awareness of related practice areas.
  2. Inform: Educate members on the latest innovations and technological trends impacting safety and pharmacovigilance. Address legislation changes and related compliance issues resulting from the UK’s planned departure from the EU.
  3. Grow: Continue to build upon our membership base to expand our active community.

CSP Community Benefits

Through the active participation of our members, the DIA CSP Community provides a forum for sharing information regarding the clinical safety and pharmacovigilance regulatory environment and for assessing new technology and methods for monitoring the safety of medical products. The Community also provides professional development opportunities through DIA CSP working groups. Recently formed working groups are addressing topics within the areas of Signaling and Risk Management, PV Quality and Compliance, and Pre/Post-Market reporting.

We host monthly conference calls and have launched a series of webinars with guest speakers. Members of our Community have the opportunity to participate in these timely and focused webinars at no additional cost. Materials from our monthly meetings and training webinars are shared with Community members and archived within our electronic library. Access to the library is included with your CSP Community membership.

Membership in the CSP Community is open to all active DIA members. If you are interested in expanding or sharing your safety and pharmacovigilance knowledge, please join us in our mission.


Nicole Baker, Consultant, Nicole Baker QPPV Ltd.

“DIA Clinical Safety and Pharmacovigilance Community is a vibrant community where professionals from a variety of backgrounds are willing to share and learn new and not so new ideas. It is a community where positive and interesting interactions happen.”

Nicole Baker, Consultant, Nicole Baker QPPV Ltd.

Reena Harjai, Director, Clinical Safety & Pharmacovigilance Operations, APCER Life Sciences

“DIA communities help a group of professionals to interact and share information that helps broaden our knowledge base. You also make contacts and these contacts are often a valuable source of information/ solution when you face a challenging situation in your profession.”

Reena Harjai, Director, Clinical Safety & Pharmacovigilance Operations, APCER Life Sciences