Pharmacovigilance Co-ordination Manager
India Permanent Posted on Apr. 28, 2025 Closing on May. 28, 2025Job title: Pharmacovigilance Co-ordination Manager
Location: Hyderabad
Main responsibilities:
PV Co-ordination manager is a centralized role that:
Participates in Country Safety Heads (CSH) meetings and involved in collating the information in a tracker about all PV Operations related queries arriving from CSHs and finding resolutions for these queries.
Responsible for oversight & tracking of queries received in Opella PV Operations Mailbox.
Responsible for all Outbound communication from PV Operations to CSHs.
Responsible for annual review of all distribution rules for all countries in collaboration with CSHs.
Responsible for annual review of product list for all countries in collaboration with CSHs.
Responsible for mentoring and on-boarding of CSHs/ Delegates & Distributors on PV Operation Tools, as needed.
Responsible for supporting and co-ordination at local level for divestment activities.
Co-ordinates meetings with Global Stakeholders.
Maintains Regional Governance SharePoint.
Responsible for PV Quality Liaison role for CSHs/ multi-CSHs for assigned group of countries by providing quality oversight across countries on the country PV deliverables and highlighting PV quality risks, issues, and mitigation plan(s) to the regional PV/ Quality Heads.
Contribute to process improvement activities.
Create relevant SOPs, Job Aids, as needed.
Other PV tasks as require
About you
Experience:
Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc.
Experience in case processing activities.
Experience in team management
Experience in overseeing vendors responsible for case processing.
Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation
Good knowledge of MS Office
6-8 years of pharmaceutical industry experience with a focus on pharmacovigilance with min 2 years in managing team
Strong experience in ICSR quality review and submissions
Incumbent should have experience in Process Improvement practices
Soft skills:
Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
Time Management: Ability to manage multiple projects and deadlines effectively, ensuring that safety reports and data analysis are delivered on time.
Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.
Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.
Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way
Excellent team-work and interpersonal skills
Ability to work in cross-functional teams
Excellent oral and written communication skills
Presentation Skills: 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: Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports
Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities.
Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards.
Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards.
Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.
Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings).
Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders.
Education:
Bachelor’s degree in pharmacy / Life Sciences / equivalent Academic qualification is desirable with 6-8 years of experience and min. 6 years in Global PV case processing activities
Languages: Fluent in English (verbal and written)
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