
Data Analytics Specialists
1 week ago
ProductLife Group is seeking a skilled professional to assume the role of Data Officer (Pharmacovigilance). The selected candidate will join our dynamic team and contribute to the activities performed in the Hub.
The successful candidate will be required to work within the Easter USA Time Zone (6.30pm to 2.30 am IST).
Responsibilities:
- Local safety case receipt, processing, and data entry as well as quality control tracking and ICSR follow-up of all safety information received for PLG clients, according to agreed timelines
- Management of 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 clients and reporters
- Periodic reconciliations to confirm the proper handling of all vigilance reports for PLG clients
- Support/contribution to local pharmacovigilance activities as needed
Qualifications:
- Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or science-related fields, or equivalent experience
- Minimum two years of experience in pharmacovigilance working for service providers performing data entry and QC of cases
- Previous experience working under deadlines
- Client communications skills
- Knowledge of US and EU PV regulations
- Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety
Skills:
- Excellent organizational and interpersonal skills
- Ability to work well within a team
- Effective time management skills
- Accountability and autonomy with assigned tasks
- Process-oriented with good attention to detail
- Excellent communication skills both written and verbal to explain complex concepts and address queries from the team
- Flexibility and adaptability to handle a dynamic workload
- Proficiency in safety database management
- US and EU PV regulations knowledge
- Pharmaceutical background
- Experience in client communications
- Excellent analytical skills
- Good writing and presentation skills
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