Sharmila Nukala
Hyderabad
Summary
Reliable management professional with several years of expertise developing top-notch skills in customer service and team leadership in the retail industry. Ready to take on new challenges in an exciting new position
Overview
10
10
years of professional experience
Work History
Associate Manager
Orcimed Life Sciences
Hyderabad
10.2025 - Current
- Manage, mentor, and develop pharmacovigilance associates and senior associates.
- Conduct performance reviews and support employee development initiatives.
- Facilitate training and onboarding of new team members.
- Oversee day-to-day pharmacovigilance activities
- Allocate resources and manage workloads to ensure operational efficiency.
- Engaged in client governance meetings to discuss operational matters and ensure alignment.
- Facilitated collaboration and information exchange between internal teams and external stakeholders to enhance project alignment.
- Identify and implement process optimization opportunities to drive operational excellence.
- Analyze quality metrics and apply corrective and preventive actions (CAPA).
- Maintain inspection readiness and support pharmacovigilance quality management activities.
- Support preparation for regulatory inspections, audits, and client assessments.
- Contribute to SOP development, revision, and implementation.
- Supported management and oversight of pharmacovigilance vendors and business partners to ensure compliance with service-level agreements.
- Monitor vendor performance against established service-level agreements (SLAs).
- Participate in vendor audits and governance activities.
Safety Process Lead
Orcimed Life Sciences
Hyderabad
05.2023 - 09.2025
- Lead and oversee end-to-end pharmacovigilance processes, including adverse event case management
- Develop, maintain, and optimize PV Standard Operating Procedures (SOPs), work instructions, and process documentation.
- Ensure compliance with global regulations, including FDA, EMA and local regulatory requirements.
- Monitor process performance through KPIs, metrics, and quality indicators.
- Support internal audits, regulatory inspections, and client audits.
- Identify process improvement opportunities and implement efficiency initiatives.
- Partner with Safety Operations, Medical Review, Regulatory Affairs, Clinical Operations, Quality Assurance, and IT teams.
- Act as a subject matter expert (SME) for pharmacovigilance processes and regulatory requirements.
- Oversaw vendor governance processes to ensure compliance and performance standards. and oversight activities related to PV operations.
- Deliver PV process training for internal teams and external partners.
Senior Safety Specialist
PPD
Hyderabad
04.2019 - 04.2023
- Review literature and quality review abstracts/articles for adverse events, special situation events, signal-relevant and aggregate-relevant safety information for both developmental and market-authorized products
- Effectively communicate with managers, team members, and client contacts
- Review compliance for literature activities on assigned projects and escalate problems or issues to Manager.
- Resolve complex problems through in-depth evaluation of various factors
- Prepare for and attend kick-off meetings and audits.
- Responsible for setting up and maintaining of literature surveillance activities for assigned projects.
- Maintain knowledge and understanding of internal and client-provided standard operating procedures (SOP) and current regulations.
- Supervised work of contracted employees to keep on task for timely completion.
Safety Expert
VigimedSafe Private Limited
Hyderabad
04.2018 - 03.2019
- Review literature and quality review abstracts/articles for adverse events, special situation events, signal-relevant and aggregate-relevant safety information for both developmental and market-authorized products
- Effectively communicate with managers, team members, and client contacts
- Review compliance for literature activities on assigned projects and escalate problems or issues to Manager
- Resolve complex problems through in-depth evaluation of various factors
- Prepare for and attend kick-off meetings and audits
- Responsible for setting up and maintenance of literature surveillance activities for assigned projects
- Maintain knowledge and understanding of internal and client-provided standard operating procedures (SOP) and current regulations
- Supervised work of contracted employees to keep on task for timely completion.
Safety Process Associate
VigimedSafe Private Limited
Hyderabad
04.2016 - 03.2018
- Performed all duties of a Safety Process Associate (SPA) as listed in job title below reports.
- Triaged individual case reports (ICSRs) to prioritize their submission to regulatory authorities as per regulatory timelines
- Reviewed literature screening search result, to identify ICSRs and other safety-related findings.
- Quality checked the cases triaged by Safety Process Associate.
- Data entry of the very complex ICSRs from different sources (post-marketing, clinical trial, literature) in to the safety database.
- Quality checked of the cases processed by Safety Process Associate and assessment of the quality error rate where appropriate.
- Initiated follow-up for literature and spontaneous cases.
- Reviewed SOPs and other guidance documents on a timely basis.
- Lead projects and communicate to the client whenever necessary.
- Generated line listings.
- Monitored, receipt, tracked and acknowledged ICSRs.
- Performed initial triage of the received safety notifications to Marketing authorization holder's (MAH) safety mailbox.
- Ensured duplicate search in the Safety Database in accordance with SOPs for all ICSRs to determine whether there is an existing case.
- Booked-in the cases.
- Imported R3/R2 XML files in Safety Database.
- Performed accurate and complete entry of data including coding of events using MedDRA and products using appropriate dictionaries such as World Health Organization (WHO).
- Summarized the narrative in chronological order. Used simple language and ensured that the essential data elements are captured in the narrative.
- Performed self-quality check before routing the case to the next workflow.
- Generated follow-up queries where necessary.
Education
Master of Pharmacy -
NRI College of Pharmacy
Andhra Pradesh01-2014
B.Pharmacy -
KVSR Siddhartha College of Pharmaceuticals Sciences
Andhra Pradesh01-2012
Intermediate -
Narayana Junior College
Andhra Pradesh01-2008
Central Board of Secondary Education -
St. Mathew's Public School
Andhra Pradesh01-2006
Skills
- Audit Experience
- Supervision
- Work Planning
- Strong Communication
- Administration
- Team Management
- Teamwork
- Project Management
- SOP development
- Performance reviewing
- Vendor management
- Process optimization
- Team leadership
- Resource allocation
- Presentations
Accomplishments
- Achieved best employee award in the year 2016 and 2017.
Best Recognition Awards in the year 2024,2025 and 2026
Languages
- English
- Telugu
Timeline
Associate Manager
Orcimed Life Sciences
10.2025 - Current
Safety Process Lead
Orcimed Life Sciences
05.2023 - 09.2025
Senior Safety Specialist
PPD
04.2019 - 04.2023
Safety Expert
VigimedSafe Private Limited
04.2018 - 03.2019
Safety Process Associate
VigimedSafe Private Limited
04.2016 - 03.2018
Master of Pharmacy -
NRI College of Pharmacy
B.Pharmacy -
KVSR Siddhartha College of Pharmaceuticals Sciences
Intermediate -
Narayana Junior College
Central Board of Secondary Education -
St. Mathew's Public School