Associate Director Pharmacovigilance

• May 2021 - Present

As Associate Director I am responsible for providing all aspects of supervision to individuals performing adverse experience case management activities within Global PV Case Management (GPVCM) in compliance with MSD/Merck Policies and Procedures, GPVCM Standard Operating Procedures (SOPs) and ICH-GCP guidelines. I play a key role in managing performance as well as providing career development opportunities and serves as a mentor for my direct reports. I am also responsible for leading critical processes within Operational Excellence pillar as well as global projects. I serve as Audit and Inspection sub-pillar lead to ensure adherence with Standard Operating Procedures and regulatory requirements, effectively collaborate and communicate with team members within process space and across process areas to ensure optimal operational effectiveness, initiate and support various process improvement, as well as independently identify gaps and propose solutions to address. I ensure effective interaction of GPVCM staff within cross-functional project teams, with key stakeholders and business partners to achieve business objectives.

Associate Manager Pharmacovigilance

• Jul 2017 - Apr 2021

As a manager I am responsible for providing all aspects of supervision to individuals supportinga functional area within GDMS. I interact effectively with project teams and business partners, and serve as first line escalation path. I provide career development opportunities and manage performance. I participate in functional area process and project initiatives. I supervise staff and interact with individuals across multiple MSD/Merck sites.

Senior Safety Data Specialist

• Oct 2016 - Jun 2017

• perform case review of adverse experience information within the establish timeframe to be compliant with internal requirements, business partners, subsidiaries and agencies• assist management to ensure key performance indicator targets are met. Assist with root cause analysis and oversee implementation of actions plans when appropriate. Provide technical level process expertise and conduct periodic assessments to ensure established processes are being followed in a consistent and appropriate manner• ensure the development, organization and implementation of the basic and PV Specific Training Plans for the Team• perform and coordinate mentoring activities for PV coordinators as appropriate based on operation and business needs• support technical issues related to PV process• actively participate and ensure effective communications with involved Global Safety and PV leads/ PV reviewers/ trainers/liaisons of other DMC locations to guarantee standard procedures are aligned• organize and actively participate in PV liaison network in order to discuss process issues, inconsistencies and work with Global Safety to improve, standardize and optimize process.

Safety Data Specialist

• Jul 2014 - Sep 2016

• analyzing, triaging, and processing all adverse experience information received for investigational and marketed products according to standard operating procedures for reporting to worldwide regulatory agencies• ensuring compliance with internal, business partner, and regulatory agency reporting requirements worldwide within the established timeframes by prioritization of activities• performing case review of adverse experience information within the established timeframes to be compliant with internal, business partner, and regulatory agency reporting requirements worldwide (since June 2015)• ensuring effective communication with international data management centers inside the company• participate/perform in training and certification activities for PV GDO• serve as local expert by ensuring the appropriate resources such as SOPs and product/protocol guidelines are available and routinely updated. Stay abreast of updates to act as resource for questions/clarifications• develop and support different strategies to improve team performance• continually monitor for opportunities for process improvement to improve efficiency and effectiveness and implement changes as appropriate

Pharmacist

• Nov 2010 - Jul 2014

Pharmacist

• Sep 2009 - Oct 2010