Pharmacovigilance Manager vacancies in Vadodara – Novumgen

Novumgen Hiring Manager – Pharmacovigilance in Vadodara

Overview of Novumgen: Novumgen is a dynamic group of Entrepreneurs and Scientists dedicated to innovation in specialty pharmaceuticals and biologicals. focus on delivering life-changing medicines emphasizes patient safety and value, making a significant impact globally.

Job Overview:

Position: Manager – Pharmacovigilance

Location: Vadodara, India

Employment Type: Full time, Permanent

Key Responsibilities:

• Development and implementation of Standard Operating Procedures (SOPs).
• Review and Perform signal management activity as per guideline and SOP.
• Preparation, review and reporting of aggregate reports (Such as PADER, PBRER and PSUR) as per regulatory requirement with compliance to guideline and SOP.
• Oversight of in-house and out-sourced PV activities and maintain monthly compliance process.
• Ensure compliance (quality, procedures, regulations, timeliness, consistency) of aggregate reports, Signal management and all EU activities.
• Facilitate safety monitoring by optimizing scientific quality documentation and data entry of safety case reports including spontaneous litigation reports.
• Management of ICSR activities as per respective regulatory requirement, including safety data accuracy in safety database.
• Training management of PV team and other stakeholder timely manner for regulatory requirement and safety awareness.
• Responsible for partner/vendor audit and communication for all PV activity.
• Preparation and review of SDEA.
• Handling of RMP program in line with innovator for UK & EMA.
• Manage a team of pharmacovigilance professionals, providing guidance and ensuring efficient workflow.
• Interface with regulatory authorities, healthcare professionals, and internal stakeholders to communicate safety information.
• Management of XEVMPD & SPOR database with timely update safety variation in line with Art. 57 guideline.

Candidate Qualifications:

• B.Pharm/ M.Pharm (Pharmacology)
• 9 to 12 years of experience in pharmacovigilance or drug safety, with at least 2 years in a managerial role.
• Knowledge of pharmacovigilance regulations (FDA, EMA, ICH) and guidelines.

Skills and Competencies:

• Strong leadership and management skills.
• Excellent communication, analytical, and problem-solving abilities.
• Attention to detail and accuracy in pharmacovigilance databases and software.

How to Apply: Interested??
Apply immediately by clicking the aforementioned link for each vacancy, or by submitting your CV and cover letter to [email protected].