Job Description:

• Conducting oversight of vendors who identify and collect adverse event and product quality complaint information and complete in-take of Pharmacovigilance safety and product complaint reports in Client’s Systems.
• Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event and product complaint information is performed in a compliant and timely manner to comply with global regulations.
• Supporting the business strategy of assisting internal and external customers in collecting information for product safety reports, products complaints related to Client products.
• Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met.
• Remaining current on knowledge and skills required for supporting Client customers.
• Supporting vendor case quality, and productivity metrics by exhibiting the Client core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Client; Decide Smart and Sure.
• Supporting and participating in audits and inspections as needed.
• Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal Client trainings as needed.
• Conducting oversight to ensure the vendor is effectively communicating using various mediums and establishing rapport with customers, colleagues, and interdepartmental groups.
• Conducting oversight in the vendors use of multiple databases to document adverse event and product complaint information.
• Supporting implementation of strategies to enhance PDI excellence in providing the highest level of customer experience.
• Acts as an adverse event and product complaint intake subject matter expert.
• Other duties may be assigned based on the need or work requirement of the organization.

Requirements:

• Bachelor’s degree of RN, BSN, or BS Pharm/PharmD required.
• 2-4 years’ clinical healthcare and previous pharmaceutical industry experience.
• Pharmaceutical industry contact centre experience preferred.
• Demonstrates ability to lead project work.
• Proven success in results-driven process management.
• Core knowledge of Industry regulations (ICH, FDA, EMEA, MHRA).
• Demonstrates strong attention to detail and problem-solving skills.
• Demonstrates strong verbal communication skills with external and internal customers.
• Demonstrates strong (speed and accuracy) documentation skills.
• Provides medical support with emphasis on the intake of medical product experiences.
• Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved.
• Works with Customer Service to provide standard information and product replacement as necessary.

Top skills:

• Strong attention to detail when reviewing cases and doing quality assessments.
• Excellence in verbal and written communication with peers, patients, and HCPs.
• Ability to provide feedback in a professional manner.
• Strategize in efficiency and technology improvements.
• Ability to work in a constantly evolving environment.

Please refer the Job description for details