Bibhishan Phad
Hyderabad
Summary
Dedicated pharmacovigilance professional with a strong focus on smart working and building strong relationships. Currently serving as a PVA/Global PV Alliance Lead at Dr. Reddy's Laboratories, effectively managing local and Global SDEA/PVAs for compliance and overseeing global templates. Demonstrated expertise as a subject matter expert during global audits, showcasing business process leadership and global PV agreement specialization from previous role at Tata Consultancy Services. Led SDEA/PVA drafting and execution, highlighting negotiation skills and fostering compliance through effective communication with LRPPV and Responsible individuals. Held positions as Senior Safety Data Analyst at Covance, Operational Specialist at IQVIA, and Junior Data Analyst at Cognizant. Expertise includes ICSR case management, regulatory submissions, PSMFs, Clinical Trial SMPs, client-partner relations, and LRPPV relations. Committed to protecting public health by ensuring the safe use of medicines.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Agreement / Global PV Alliance Lead
Dr. Reddy's Laboratories
09.2023 - Current
- Responsible for managing 300+ Safety Data Exchange Agreements (SDEA) / pharmacovigilance Agreements (PVA), 50+ Service Agreements with PV clause and 50+ Patient Support Programs with PV obligations. Managing these activities involves creating, negotiating, and maintaining Local and Global contracts in accordance with regulatory requirements.
- The position includes overseeing the periodic revision of agreements, designing global templates, and maintaining a comprehensive list of agreements with PV obligations
- Additionally, the role entails evaluating agreements for compliance, supporting implementation post-signing, and ensuring ongoing adherence to terms
- Acts as a Subject Matter Expert (SME) during audits and regulatory inspections globally, while also fostering key relationships with stakeholders, such as Local Responsible Person for Pharmacovigilance (LRPPV), Regional PV Leads and legal teams
Business Process Lead/Global PV Agreement Specialist
Tata Consultancy Services
09.2021 - 09.2023
- Safety Data Exchange Agreements (SDEAs) drafting and execution in alignment with commercial agreements and regulatory standards
- Proven ability to lead negotiations, ensuring that agreements not only meet business objectives but also encompass vital pharmacovigilance (PV) provisions mandated by regulatory bodies
- Ensures the implementation and compliance of a local PVA to safeguard patient's and clinical trial subject's safety and public health in compliance with regulatory requirements and applicable internal procedures and processes
- Responsible for the entire lifecycle of 130+ SDEAs, from initiation to periodic revisions
- Manages the ongoing review and update process to guarantee that all provisions remain current and comply with evolving regulatory requirements
- Pioneers the development of standardized global templates, streamlining processes and enhancing efficiency across regions
- Demonstrates exceptional organizational skills by maintaining a comprehensive global master list of agreements with PV obligations, validating and enhancing existing regional lists
- Championing post-signing implementation processes, oversees compliance with SDEA terms and conditions, providing vigilant updates during internal compliance meetings
- Serves as a subject matter expert during audits and regulatory inspections, ensuring seamless navigation of SDEA-related queries
- In addition, plays a crucial role in supporting PV due diligence for new product acquisitions and divestment's
- With an eye for detail, they generate agreement lists essential for the creation of the Pharmacovigilance System Master File (PSMF)
- Coordinated weekly meetings for internal and external groups.
- Mentored and guided employees to foster proper completion of assigned duties.
Senior Safety Data Analyst
Covance
02.2020 - 09.2021
- ICSR Processing: Involved in the processing of Clinical Trial and Spontaneous Individual Case Safety Reports (ICSRs), which involves collecting, assessing, and documenting safety information related to pharmaceutical products
- Review and Submission: Responsible for reviewing and ensuring the accuracy of safety data before submission to regulatory authorities
- This includes compliance with regulatory requirements
- Drafting, Review, and Finalization of Project Documents: Involved in the creation, review, and finalization of 10+ Safety Management plans (SMP) and various project-related documents, ensuring completeness and compliance with applicable guidelines
- SAE Reconciliation: Managing Serious Adverse Event (SAE) reconciliation, which involves comparing and aligning safety data between various sources to ensure accuracy and consistency
- Client-Partner Relations and Query Handling: Engaged in maintaining strong relationships with clients and partners
- Handling queries and concerns related to safety data, ensuring effective communication and resolution
- Mentoring and Team Sensitization: Played a role in mentoring team members and sensitizing them to adhere to Pharmacovigilance (PV) compliance
Operational Specialist 1
IQVIA
11.2018 - 01.2020
- In my role, I specialized in Investigator Alert Letter (IAL) regulatory submission, meticulously managing the intake of Lifecycle Safety data
- My responsibilities included receiving and documenting emails from investigative sites, conducting thorough triage of cases for submission in ARGUS, and adhering to regulatory guidelines for scheduling reports
- A key aspect of my work involved organizing and scheduling SUSAR documents in ARGUS, aligning with stringent regulatory timelines
- I ensured timely submission of reports to various entities, including Investigators, US FDA, US FDA MedWatch, and Country-Specific authorities, meticulously overseeing the submission process through Gateway to guarantee compliance and accuracy
Junior Data Analyst
Cognizant
05.2016 - 11.2018
- Diligently overseeing the pharmacovigilance process, I have played a pivotal role in ensuring the meticulous recording, review, and reporting of literature articles and abstracts for adverse events across diverse sources, including clinical, spontaneous, and aggregate reports
- My responsibilities also encompassed guaranteeing the accuracy, completeness, and consistency of data entry for adverse event reports sourced from various documents, including PMS, Spontaneous, E2B, Clinical Trial, and literature
- In addition to my meticulous data management duties, I took the initiative to foster a culture of continuous improvement within the team
- This involved conducting team huddles and organizing refresher trainings to thoroughly discuss both internal and external client feedback and updates
- Participated in project planning meetings, ensuring that data requirements were clearly defined and understood by all team members involved.
Territory Business Manager
Abbott
06.2015 - 02.2016
- Achieve sales target for the respective territory by utilizing all the available resources provided by the organization with monthly growth of 2 percent
- Increased sales by developing and implementing strategic territory plans and effective marketing campaigns.
- Strengthened relationships with key clients through regular visits, providing product updates, and addressing concerns promptly.
Education
Bachelor of Pharmacy (B.Pharm.) - Pharmacy
Bharati Vidyapeeth College of Pharmacy
Mumbai, India01.2015
Skills
- Content Delivery
- Rapid Learning
- Focused Execution
- Collaborative Problem Solving
- Project Management
- Knowledge of global regulations including FDA, EU & emerging market guidelines
- Customer engagement
- Client acquisition
- Aspirational Growth Mind-set
Certification
Registered Pharmacist, Maharashtra State Pharmacy Council, India, 267176
Listening Music, Travelling, Marathons
I love listening Music, travelling and participating in marathons
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Accomplishments
1) On The Spot Award - Tata Consultancy Services: On the spot award from Compliance Lead of client for the great contribution in Partner Audit
2) Contextual Master Award - Tata Consultancy Services: Contextual Master Award for preparing the PV agreement manual that includes sections / guidance on management of local and global PVAs from start to end process
3) Four Spotlight Awards - Dr. Reddy's Laboratories: a) From Reporting Manager: supported on last minute request on preparing PSMFs data deliverable and meeting the deadline, appreciated for flexibility and reliability. b) From Local Affiliate: provided support on executing local PV agreements as per the local HA requirements c) From Global Head of PV: demonstrated high level of attention to detail a review the important and crucial PVA between Partner and DRL d) From legal team: thanks for being a very detail oriented and cooperative business partner. Commitment to reach a favorable outcome.
Timeline
Pharmacovigilance Agreement / Global PV Alliance Lead
Dr. Reddy's Laboratories
09.2023 - Current
Business Process Lead/Global PV Agreement Specialist
Tata Consultancy Services
09.2021 - 09.2023
Senior Safety Data Analyst
Covance
02.2020 - 09.2021
Operational Specialist 1
IQVIA
11.2018 - 01.2020
Junior Data Analyst
Cognizant
05.2016 - 11.2018
Territory Business Manager
Abbott
06.2015 - 02.2016
Registered Pharmacist, Maharashtra State Pharmacy Council, India, 267176
Bachelor of Pharmacy (B.Pharm.) - Pharmacy
Bharati Vidyapeeth College of Pharmacy
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