Pharmacovigilance Co-ordination Manager

Job 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)