Pharmacovigilance Co-ordination Manager
Location: Hyderabad, India
Employment Type: Permanent
Posted on: Apr. 28, 2025
Closing on: May. 28, 2025
Main Responsibilities:
Participate in Country Safety Heads (CSH) meetings and assist in collating information in a tracker regarding PV operations-related queries from CSHs, and resolve these queries.
Responsible for oversight and tracking of queries received in Opella PV Operations Mailbox.
Manage all outbound communication from PV Operations to CSHs.
Oversee the annual review of all distribution rules and product lists for all countries in collaboration with CSHs.
Mentor and onboard CSHs, delegates, and distributors on PV operation tools as needed.
Support and coordinate local level activities for divestment processes.
Coordinate meetings with global stakeholders.
Maintain Regional Governance SharePoint.
Act as the PV Quality Liaison for CSHs/multi-CSHs for assigned countries, providing quality oversight and highlighting PV quality risks, issues, and mitigation plans.
Contribute to process improvement activities and create relevant SOPs and job aids as required.
Perform other PV-related tasks as assigned.
About You:
Experience:
Proficient in PV databases like ARGUS, Aris-G, VAULT Safety, LSMV, etc.
Experience in case processing activities.
Proven experience in team management and overseeing vendors responsible for case processing.
Deep understanding of safety/pharmacovigilance processes, regulations (ICH GVP, GxP), and systems validation/documentation.
Strong experience in ICSR quality review and submissions.
Familiar with process improvement practices.
Minimum of 6-8 years in the pharmaceutical industry, with at least 2 years in managing teams.
Soft Skills:
Strong stakeholder management, negotiation, and communication skills.
Effective time management, able to handle multiple projects and deadlines while ensuring timely delivery of safety reports and data analysis.
High attention to detail, analytic, proactive, and problem-solving skills.
Excellent organizational and project management abilities.
Strong team work and interpersonal skills, with the ability to work cross-functionally and in a multicultural environment.
Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way.
Technical Skills:
Understanding of adverse event reporting and regulatory requirements (e.g., CIOMS forms, EudraVigilance, FDA REMS).
In-depth knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH, etc.).
Familiar with Good Pharmacovigilance Practices (GxP) and ensuring adherence to industry standards.
Experience with safety databases like Aris-G, LSMV, Argus Safety, or VigiBase.
Advanced skills in Microsoft Office Suite (Excel for data analysis, Word for report writing, PowerPoint for presentations).
Experience with Business Intelligence tools like Power BI or Spotfire to create visual reports and dashboards.
Education:
Bachelor’s degree in Pharmacy, Life Sciences, or equivalent academic qualification.
6-8 years of experience in global PV case processing activities, with at least 6 years in the pharmaceutical industry.
Languages:
Fluent in English (verbal and written).
Additional Information:
At Sanofi, we provide equal opportunities to all individuals, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Join us to embrace new ideas and explore opportunities to make miracles happen.
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