- Argus
- Aris G
Afride Shaik
Bengaluru
Summary
Well-qualified Drug Safety Associate bringing case processing abilities developed over two and half year in Pharmacovigilance career.
Enthusiastic Drug Safety Associate eager to contribute to team success through hard work, smart work, attention to detail and excellent organizational skills. Clear understanding of Pharmacovigilance, motivated to learn, grow and excel in Pharmacovigilance.
Solid background in case Processing and data entry with good quality.
Friendly colleague available for weekend, evening and holiday shifts.
Considered hardworking, punctual and driven.
Organized and dependable candidate successful at managing multiple activities with a positive attitude, willingness to take an added responsibilities to meet team goals.
Hardworking and passionate job seeker with strong organizational skills eager to perform in any field and ready to help team achieve company goals.
Active participation and contribution in department level initiatives.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Operations Specialist 1
IQVIA
03.2023 - Current
- Demonstrate commitment to company culture of compliance, including by adhering to company code of conduct and policies and completing all mandatory assigned training on time.
- Demonstrate improvement in performance parameters (like productivity, quality, compliance, ownership etc.)
- Meet growth chart as per project.
- Active participation and contribution in department level initiatives.
- Voluntarily taking up additional responsibilities.
- Exhibits competency/skills to move role.
- Process Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information.
- Determining initial/update status of incoming events.
- Database entry.
- Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To ensure compliance to all project related processes and activities.
- Identify quality problems, if any, and bring them to attention of senior team member.
- To demonstrate problem solving capabilities.
- To mentor new team members, if assigned by Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- 100% compliance towards all people practices and processes.
- Perform other duties as assigned.
Drug Safety Associate 1
IQVIA
09.2021 - 03.2023
- To Prioritize and complete assigned trainings on time.
- Process Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information.
- Determining initial/update status of incoming events.
- Database entry.
- Coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To ensure compliance to all project related processes and activities.
- Identify quality problems, if any, and bring them to attention of senior team member.
- To demonstrate problem solving capabilities.
- To mentor new team members, if assigned by Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- 100% compliance towards all people practices and processes.
- Perform other duties as assigned
Executive
WISSEN INFOTECH
11.2020 - 08.2021
- Worked as contractor for IQVIA in vaccine project.
- To Prioritize and complete assigned trainings on time.
- Book in and Quality check of cases.
- Database entry as per project requirement.
- Worked as SME in Quality work flow team.
- Process Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To Ensure compliance to all project related processes and activities.
- Identify quality problems, if any, and bring them to attention of senior team member.
- To Demonstrate problem solving capabilities.
- To Mentor new team members, if assigned by Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- 100% compliance towards all people practices and processes.
- Perform other duties as assigned.
Pharmacist
Medlife international private limited
10.2019 - 07.2020
- Observation and able to Read Prescriptions and Digitizing Prescription.
- Managed over 50 customer calls per day regarding Prescription (Rx) & Medicines.
- Able to Process Medicines name as per Prescription without any errors.
Education
Advanced Post Graduate Program - Clinical Research, CDM, PV And Medical Writing
CLINI INDIA
Hyderabad2021-01
Bachelor of Science - Pharmacy
Hindu College of Pharmacy
Guntur, Andhra Pradesh2019-04
Skills
ADR, Serious Adverse Reaction, SAE, MedDRA, Risk Management, Pharmacovigilance role, adverse drug reaction, SUSAR, ICH guidelines, Schedule Y, Adverse event reporting (MedWatch form), Case process unit/ data entry ( triage unit), Case assessment ( expectedness, causality, expedited of event),Narrative writing, Medical Terminologies
Processing safety data according to applicable regulations, guidelines, standard operating procedures (SOPs) and project requirements Perform pharmacovigilance activities as per project requirement including but not limited to, collecting and tracking incoming adverse events (AE)/endpoint information, determining initial/update status of incoming events, database entry, coding AE and products, writing narratives and literature related activities
ICH E6 Guidelines, E2A-2F Pharmacovigilance Guidelines, Case processing, Good Knowledge of Medical Terminology and Narrative Writing
Competent with all Microsoft Office applications (Word, Excel, Power point) and Internet applications
Establish skillsets to handle case types as per project
Learning VBA and Macros
Software
Sapphire
Certification
Licensed Pharmacist
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Telugu
Advanced (C1)
Timeline
Operations Specialist 1
IQVIA
03.2023 - Current
Drug Safety Associate 1
IQVIA
09.2021 - 03.2023
Executive
WISSEN INFOTECH
11.2020 - 08.2021
Pharmacist
Medlife international private limited
10.2019 - 07.2020
Advanced Post Graduate Program - Clinical Research, CDM, PV And Medical Writing
CLINI INDIA
Bachelor of Science - Pharmacy
Hindu College of Pharmacy
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