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.
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Pharmacovigilance Professionals Wanted at Novumgen Pvt Ltd, Vadodara[/caption]
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.
https://pharmastuff.org.in/job/novumgen-manager-pharmacovigilance-vadodara?feed_id=10831
