Instagram
youtube
Facebook

Pharmacovigilance Project Manager

3-5 years
Not Disclosed
1 Feb. 26, 2025
Job Description
Job Type: Full Time Education: B Pharm / M Pharm / MPH / MBA (Healthcare Management) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📢 We're Hiring!

📌 Pharmacovigilance Project Manager
📍 Location: Hyderabad
▪️ Education: B Pharm / M Pharm / MPH / MBA (Healthcare Management)
💼 Experience: 3-5 years in Pharmacovigilance Project Management


◾ Roles and Responsibilities:
🔹 Serve as the primary point of contact for project-related communications with both external and internal stakeholders.
🔹 Establish and maintain strong client relationships, ensuring consistent delivery of high-quality work and addressing any concerns promptly.
🔹 Develop project scope, timelines, and objectives based on the signed agreement between the client and Navatio Pharma.
🔹 Plan, track, and manage project activities, ensuring deadlines are met and milestones are achieved on time.
🔹 Oversee and report project progress, providing regular updates to clients and internal stakeholders (e.g., Monthly reports, used for invoicing and performance tracking).
🔹 Monitor and manage project budgets, resource allocation, and timelines to ensure efficient project execution.
🔹 Ensure compliance with relevant regulatory requirements and adherence to internal SOPs and Quality standards.
🔹 Facilitate project meetings, ensure clear communication of goals, and resolve any issues that may arise during the project lifecycle.
🔹 Coordinate with cross-functional teams (e.g., safety operations, medical affairs, regulatory affairs) to ensure successful project execution.
🔹 Support the preparation and submission of safety reports, such as PADERs, PSURs, DSURs, and other regulatory documents.
🔹 Train and mentor staff in pharmacovigilance processes, regulatory requirements, and best practices.
🔹 Prepare for and support pharmacovigilance audits and regulatory inspections.
🔹 Implement corrective actions as necessary following audits and inspections.
🔹 Stay up to date with the latest trends and regulatory changes in pharmacovigilance.

📢 Qualifications:
✔️ Experience in Pharmacovigilance Project Management (preferably in a CRO).
✔️ Bachelor’s in Pharmacy, Life Sciences, Medicine (Master’s is a plus).
✔️ Expertise in ICSR processing, PADERs, DSURs, PSURs, RMPs, signal management & literature monitoring.
✔️ Strong project management, team coordination & client-facing skills.
✔️ Proficiency in MS Office & project management tools.
✔️ Excellent communication, multitasking & compliance handling abilities.
✔️ Ability to manage multiple projects while ensuring high-quality standards.

📢 Join us and be a part of a dynamic team ensuring patient safety worldwide!
📩 Apply now or refer a suitable candidate! 
📧 Email your resume to: hr@navatiopharma.com