· Provide phone support to health care professionals, customers and patients, involving receipt and tracking of medical inquiries, adverse events, product quality complaints, and other types of calls as required.

· Receive and document incoming telephone calls, fax or emails from various sources including business partners during regular weekday business working hours.

· Establish and maintain effective team communications i.e. provide regular feedback to the local management team on project metrics, out-of-scope work challenges/issues, and successes.

· Writes the SOPs and Working Instructions in order to implement the Medical Information receipt system and ensure compliance to FDA regulations and timelines.

· Triage incoming reports for completeness, legibility, and validity.

· Preparation for, participation in, and follow-up on audits and inspections by regulatory agencies and clients.

· Coordinate with various sites and PV service providers to ensure smooth process flow of information and timely submissions to regulatory agencies.

· Verification and archival of documents related to Medical Information/Pharmacovigilance.

· Support to group companies on PV activities.

· Any other work assigned by the supervisor.

Requirements and Qualifications:

· Bachelor’s degree with 3-5 years’ experience in Medical Information operations related to pharmaceutical Industry.

· Hands on experience on using IRMS software is preferred.

· Excellent written and verbal skills in English.

· Excellent professional telephone behavioral skills.

· Ability to work flexibly, organize own workload and effectively manage competing priorities.

· Excellent attention to detail and accuracy maintaining consistently high-quality standards.

· Ability to establish and maintain effective working relationships with coworkers, managers and clients.

· Willingness to learn new skills and flexibility to support business needs

· Apply knowledge and expertise, to contribute to and provide solutions to process improvements

· Experience in Lifecycle safety (Pharmacovigilance, Medical Information, Aggregate Reporting, Risk Management etc.) is a distinct asset.