Job ID 205337BR
Position Title Sr.
Pharmacovigilance Expert
Country India
Work Location Hyderabad
Company/Legal Entity Novartis
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description
Provide support for medical safety
management within the IMS Department, including single case medical review and
related activities, aggregate reports including coordination and management of
large datasets for analysis purposes, and preparation of responses to Health
Authorities, within agreed timeframes and to a high standard of accuracy, in
compliance with DS&E business rules, standard operating procedures and
global and local regulatory requirements. Performs signal detection for
assigned products in the Empirica Signal tool. Provide input to medical safety
aspect for dedicated projects, lead internal management teams such as SPT or
SMT.
1.Performs medical review of single cases from all sources, including review of
events associated to quality defects
2. Manages or supports the preparation and review of Investigator Notifications
(INs) and distributes INs
3. Performs signal detection and signal evaluation activities for assigned
products, and SMaRT topic updates
4. Authors or co-authors the medical sections of periodic reports (PBRER, DSURs
per project assignment), assists in or leads the preparation of other safety
related documents, including Investigator Brochures (IB), Core Data Sheets
(CDS), Product Guidance Documents (PGD), Expert Statements, and Responses to
Health Authorities inquiries
5. With BSL/PVL’s support, assists in the development, maintenance and
implementation of RMP including the coordination with other line functions for
associated activities such as updates, management of large datasets for
analysis purposes and the ongoing tracking of commitments and effectiveness
measures. The Sr. PVE will assume increasingly independent ownership of these
processes
6. Regularly and independently contributes to the evaluation and writing of the
medical sections of other study deliverables including, but not limited to,
clinical overviews, ad hoc Health Authority queries, Drug Safety Product
Profile (DSPP), and Drug Safety Update Report (DSUR)
7. Regularly interfaces with the clinical team for safety matters, including
follow-up on events of interest, input into site queries regarding adverse
events, and updating Team on PVO requirements
8. For tasks assigned by BSL/PVL, acts as the main IMS contact at internal
management teams as SPT, SMT, GPT, and for licensing collaborations
9. Supports preparation for and participates on internal safety reviews boards,
such as SMT, MSRB, and SIGDET
10. Provides support to BLS/PVL for quality assurance activities, internal
audits, and Health Authority inspections
11. Acts as Deputy for product specific PVLs, assuming full responsibility
during the deputation period
12. Lead the training and mentoring of newly recruited colleagues by supporting
their integration into the PVE role. Note: While the majority of the
responsibilities are the same as for PVEs, the primary considerations for Sr.
PVE include the seniority, relevant experience and ability to perform major
tasks defined in Job Description consistently and independently, with minimal
supervision.
1. Quality of work delivered (attention to details, thoroughness, medical sound judgment, and medical writing skills)
2. Writing concise, accurate and quality documents
3. Timeliness of deliverables according to established directives
4. Compliance with Internal and external regulations and procedures
5. High level of independence
6. Effective communication with- and support to- product safety Colleagues and project functions
Minimum requirements
Bachelor of Science in
Pharmacy /Bachelor of Science in Nursing / PharmD/ or Medical
Degree (MBBS or MD) Good knowledge/fluency in English. Knowledge of other
languages desirable.
• 3-6 years prior experience in clinical research or its equivalent with a
minimum of 3 years of drug safety experience preferred. May be a first job in
the pharmaceutical industry for an MBBS/MD with 3 years clinical experience
postdoctoral• Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred
• Excellent understanding of clinical trial methodology, GCP and medical terminology
• Attention to detail and quality focused
• Ability to operate effectively in an international environment
• Excellent understanding of physiology, pharmacology, and the drug development process including its interactions with HAs
• Strong technical and problem solving skills
• Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.
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