Assistant Manager, Pharmacovigilance

Novugen; Shah Alam; On-site; MYR 120,000 - 180,000; Full time

Job summary

Novugen Pharma (USA) LLC in Malaysia is seeking an Assistant Manager for Pharmacovigilance to set up the PV system and lead safety activities across markets.

You will manage AE/ICSR reporting, PSURs, RMPs, CAPAs, and liaise with regulators, while building SOPs and training staff in a fast-growing pharmaceutical environment.

Qualifications

• Must have degree in Pharmacy, Life Sciences, Microbiology or Chemistry or related discipline.
• Minimum 6 years of PV experience, with supervisory or leadership responsibilities.
• Knowledge of Malaysian PV regulations and EMA/FDA/ICH guidelines.
• Hands-on experience in adverse event reporting, PSURs, RMPs and PV quality systems.

Responsibilities

• Manage the collection, assessment, processing and reporting of adverse events and ICSRs.
• Ensure timely submission of safety reports to regulatory authorities.
• Oversee PV databases, case documentation, data quality and record management.
• Coordinate follow-up activities and communication of relevant safety information to stakeholders.

Skills

PV leadership

Analytical skills

Stakeholder management

Regulatory knowledge

Education

Bachelor degree in Pharmacy / Life Sciences

Tools

PV databases

Safety management systems

Job description

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the Role

The Assistant Manager for Pharmacovigilance (PV) is responsible for the set-up of the PV system in the company, support the PV team in ensuring the safety of pharmaceutical products through detection, assessment, understanding, and prevention of adverse effects and any other drug-related problem. This role also involves managing PV activities, work according to good pharmacovigilance practice, coordinating with cross-functional teams, ensuring compliance with regulatory requirements and maintain a good rapport with regulatory authority.

Key Responsibilities:-

Pharmacovigilance Operations

• Manage the collection, assessment, processing and reporting of adverse events and Individual Case Safety Reports (ICSRs).
• Ensure timely submission of safety reports to the relevant regulatory authorities in accordance with applicable requirements.
• Oversee PV databases, case documentation, data quality and record management.
• Coordinate follow-up activities and communication of relevant safety information to stakeholders.

Regulatory Compliance & Safety Management

• Ensure compliance with Malaysian and applicable international pharmacovigilance regulations, guidelines and Good Pharmacovigilance Practices (GVP).
• Coordinate the preparation, review and submission of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and other required safety documentation.
• Support signal detection, safety evaluation, benefit-risk assessment and implementation of risk minimisation measures.
• Liaise with regulatory authorities and support responses to pharmacovigilance-related queries.

PV System Development & Quality Management

• Support the establishment and continuous improvement of a centralised PV system covering multiple markets.
• Develop, implement and maintain PV Standard Operating Procedures (SOPs), processes and compliance frameworks.
• Support PV audits and regulatory inspections, including implementation and follow-up of Corrective and Preventive Actions (CAPAs).
• Ensure appropriate documentation, traceability and inspection readiness of PV activities.

Cross-functional Coordination & Training

• Collaborate with Regulatory Affairs, Quality Assurance, Medical Affairs and other relevant functions to ensure effective PV operations.
• Coordinate PV-related activities with business partners and external stakeholders, as applicable.
• Conduct pharmacovigilance awareness and compliance training for relevant employees.
• Monitor regulatory developments and recommend improvements to existing PV practices and processes.

About You

• Must possess a Degree in Pharmacy (BPharm), Life Sciences, Microbiology, or Chemistry or a related discipline.
• Minimum 6 years of relevant experience, preferably including supervisory or team leadership responsibilities.
• Practical experience in pharmacovigilance within the pharmaceutical or healthcare industry.
• Knowledge of Malaysian pharmacovigilance requirements and international regulatory frameworks, including relevant EMA, FDA and ICH guidelines.
• Hands-on experience in adverse event reporting, safety documentation, PSURs, RMPs and PV quality systems.
• Familiarity with pharmacovigilance databases and safety management systems.
• Strong analytical, organisational and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Proactive, resourceful and capable of working independently.
• Strong attention to detail with a commitment to regulatory compliance and patient safety.
• Ability to manage multiple priorities in a dynamic, evolving environment.
• Experience in establishing or improving PV systems and processes will be an added advantage.