Data Officers (Pharmacovigilance)

ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.

You will be required to work Easter USA Time Zone (6.30pm to 2.30 am IST)

Responsibilities :

To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required

Management of the generic or client specific email boxes as appropriate.

Registration, triage, assignment and coordination for the processing of vigilance cases

Follow-up requests with local reporters

Responding to queries from client and reporters

To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients

Support / Contribute to local pharmacovigilance (PV) activities performed by the Local safety / PV department as needed

To participate in audits / inspections and resulting action plan

Education and Experience :

Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience

2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases

Previous experience working to deadlines.

Client communications

Knowledge of US and EU PV regulations

Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.

Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment

Skills :

Excellent organizational and interpersonal skills

Ability to work well within a team

Excellent time management skills

Accountability and autonomy with assigned tasks

Process orientated with good attention to detail

Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.

Flexibility and adaptability to handle a dynamic workload

Works well under pressure and working to timelines

Safety database experience