Overview

Novumgen – The group of Entrepreneurs and Scientists.

Novumgen is a diverse, integrated specialty pharmaceutical and biological company focused on investing, developing, manufacturing, and supplying innovative products that provide benefits to patients and prescribers. We are focused on delivering life-changing medicines that contribute safety and value to patients, healthcare institutions, and prescribers across the globe. As a company, Novumgen has made a lasting commitment to patient safety, introducing new products to our portfolio while maintaining unrivalled quality and exceptional service to the pharmaceutical industry

We are currently looking to recruit a Human Resources Advisor, with experience in the UK to cover a period of maternity leave, with the view to become permanent, dependent on company growth. The role of the Human Resources Advisor is to give counsel to the company regarding our human resource policies and procedures. The main duties will include offering guidance on employee recruitment and retention, evaluating employee performance, and maintaining employee relations

Candidate Duties

• 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 Qualification

• B.Pharm/ M.Pharm (Pharmacology)

Candidate Requirements

• 9 to 12 Years of experience in PV domain or drug safety, with at least 2 years in a managerial or supervisory role.
• Experience in regulatory reporting, adverse event management, risk management, and signal detection.
• Knowledge of pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).

Skills and Competencies

• Strong leadership and management skills.
• Excellent communication skills, both written and verbal.
• Analytical and problem-solving skills.
• Attention to detail and accuracy.
• Ability to work effectively in a cross-functional team environment.
• Proficiency in pharmacovigilance databases and software (e.g., ARGUS, ARISg).