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Bausch + Lomb Corporation, (NYSE/TSX: BLCO), is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.

The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses, and other eye surgery products.

Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.

Over the last 167 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.

OBJECTIVES/ PURPOSE OF JOB

The incumbent supports assigned APAC regional Pharmacovigilance activities. In addition, this function will support the assigned local and global PV work or GDCM team.

KEY ACTIVITIES/ RESPONSIBILITIES

• Providing guidance and expertise as required, meeting local and international vigilance reporting obligations for adverse events and special situations

• Participation in further activities related to Pharmacovigilance safety issues: PV Audit support, non-conformance record management, and Corrective and Preventative Action (CAPA)

• Cooperation with Regulatory Affairs and Medical Affairs Departments in Field Safety Notice (FSN) preparation, as and when required

• Contribute to the GPRM plans and strategies by communicating current local laws and regulations

• Provide direct support to the Local Responsible Person for Pharmacovigilance (LPPV) from the GPRM team

• Assist local affiliate(s) in preparing expedited safety reports or aggregate reports for submission to the relevant health authorities

• Develop and maintain proficiency in all company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and Investigator's Brochure (IC), as well as relevant legal and ethical standards, ensuring alignment with global requirements

• Manage and directly support the development, review, and execution of Safety Data Exchange Agreements (SDEAs), ensuring compliance with Company SOPs, local regulations, and international guidelines

• Contribute to the development, revision, and updating of local PV SOPs, as well as global/regional SOPs and Work Instructions, to ensure compliance with both local regulatory agency requirements and global/regional PV SOPs

• Review and analyze metrics for critical drug safety processes to ensure adherence to company SOPs, relevant regulatory requirements, and international guidelines

• Contribute to continuous improvement processes as required

• Contribute to integration processes for vigilance operations following company acquisitions (e.g., company, portfolio, products) to maximize efficiencies and ensure compliance with the local regulatory agency requirements and global/regional PV SOPs

• Manage and provide direct support in developing training materials and conducting training for new hires and local affiliates within the APAC region on safety reporting, ensuring alignment with company SOPs, as well as, local and international laws and guidelines, as necessary

• Provide support to local affiliate(s) regulatory affairs for product registration, renewal, and ongoing safety reporting within each affiliate country/region, as needed

• Provide support to local affiliate(s) and/or EEA QPPV office regarding the PSMF update to ensure compliance with the regulatory agency requirements and global/regional PV SOPs

EXPERIENCE

• A minimum of 5 years of working experience in a similar field

• Preferably someone with experience in pharmacovigilance/Post Marketing Surveillance (PMS) or related area in the pharmaceutical industry or medical environment

• Knowledge of general medicine or pharmacy or clinical practice to conduct pharmacovigilance activities

• Understanding of local/international pharmacovigilance regulations

• Proficient in safety databases, preferably ARISg

• Good communication, listening and problem-solving skills

• Must be attentive to details, resourceful, and self-motivated with the ability to work under pressure and urgency in meeting tight deadlines

• Good knowledge of MS Office such as Excel, Word and PowerPoint

• Must be able to speak and write in English and Chinese

• Able to work independently

The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on reques.