Dancing
Aakriti Singh
Sr. Safety and PV Specialist
Gurugram
Summary
Results-driven Senior Safety and Pharmacovigilance Specialist with a robust foundation in specialized tasks and a proven track record of delivering impactful results through targeted initiatives. Expertise in implementing effective strategies that enhance operational efficiency while aligning with team objectives. Strong problem-solving skills and extensive project management experience contribute to successful outcomes in complex environments. Committed to fostering a culture of safety and compliance, ensuring organizational goals are consistently met or exceeded.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr. Safety & PV Specialist
Syneos Health
11.2016 - Current
- Mastered case processing activities, including triage and ICSR handling, in alignment with program-specific safety plans and SOPs.
- Conducted triage of ICSRs with strong understanding of seriousness criteria, ensuring accurate prioritization and classification.
- Performed Quality Checks (QC) on all case types to maintain compliance and data integrity across the program.
- Assisted in drafting and reviewing Safety Management Plans (SMPs) as per project requirements.
- Independently generated expedited safety reports (CIOMS, MedWatch, XML) for regulatory submission.
- Provided mentorship and guidance to junior case managers, enhancing team performance and knowledge sharing.
- Participated in Pharmacovigilance audits and inspections, contributing to successful compliance outcomes.
- Delivered sponsor trainings to new and experienced associates, ensuring alignment with safety protocols and expectations.
- Processed ICSRs per SOPs, including coding of adverse events, medical history, concomitant medications, and lab tests.
- Compiled narrative summaries with clinical accuracy and regulatory relevance.
- Assessed and initiated follow-ups for missing or incomplete data, ensuring case completeness and regulatory readiness.
- Demonstrated strong knowledge of global regulations (GCP, ICH, GVP), Work Instructions (WIs), and drug development lifecycle.
- Acted as a liaison between internal teams, sponsors, vendors, and regulatory authorities in safety and pharmacovigilance matters.
- Ensured timely and accurate reporting of expedited cases to sponsors and health authorities in compliance with applicable regulations.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Followed all company policies and procedures to deliver quality work.
- Proactively initiated and managed follow-up communications with healthcare professionals and reporters to gather critical patient data for ICSRs, improving data quality and supporting accurate medical assessment.
Education
M. Pharm - Pharmacology
08.2016
Research Project: "To evaluate the in-vivo effect of needles extract of plant Pinus roxburghii Sarg. using Wistar albino rats."
B. Pharm - undefined
08.2014
Completed one month training in Akums Pharmaceuticals under quality assurance department.
Skills
Effective team player
Certification
Product Manager- ISB-Ongoing certification
EXTRACURRICULAR ACTIVITIES
- Anchored the Dance Event at the National Technical cum Cultural Festival, Mahatma Jyotiba Phule Rohilkhand University
- Active member of Funtoo Activity Team, regularly organizing fun and interactive events at the workplace to boost team morale and foster a positive work culture
Additional Information
Languages: English and Hindi
Technical Skills: Safety database tools (Argus, Mosaic), CATool, CIRE, MedDRA coding, WHO drug dictionary and Company drug dictionary
Recognition: Top performer (Syneos Health), received recognition on timely delivery
Availability: Available to join within 60 days
Interests
Meditation
References
Rekha Pandey [Sr. Safety and PV Specilaist, Syneos Health], [Mob. No.: 08826638619]
Samriddhi Sharma [Manager, Syneos Health], [Mob. No: 8427733396]
Timeline
Sr. Safety & PV Specialist - Syneos Health
11.2016 - Current
Mahatma Jyotiba Phule Rohilkhand University - B. Pharm,
Department of Pharmaceutical Sciences, Kumaon University - M. Pharm, Pharmacology
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