Job ID 190971BR
Position Title Pharmacovigilance Expert
Division Pharma
Business Unit Global Develop NPH
Country India
Company/Legal
Entity India
Novartis Healthcare Private Limited
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description Provide support to the Brand Safety
Leader/Pharmacovigilance Leader (PVL/BSL) in monitoring the safety profile of
assigned products by providing quality deliverables within agreed timeframes
and adhering to a high standard of accuracy in compliance with IMS business
rules, standard operating procedures and global and local regulatory
requirements.
1. Assist the
BSL/PVL in monitoring the safety profile of products potentially including
activities such as literature review, evaluation of individual cases or signal
detection. Medical review of single case reports will be performed by
associates possessing medical degree.
2. Together with
the BSL/PVL, co-author the PSUR including analytical input to PSUR for known
and potential risks defined in the RMP.
3. With BSL/PVL,
assist in the development, maintenance and implementation of the 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
4. Assist in
evaluating and writing other safety deliverables including but not limited to
clinical overviews, ad hoc health authority queries, drug safety product
profile (DSPP), drug safety update report (DSUR)
5. Assist in
providing safety input to DRA and clinical documents (e.g. core data sheet and
investigator brochure)
6. Play an active
role in standing and ad hoc Safety Management Team (SMT) and Safety Project
Team (SPT) meetings
7. Play an active
role in SIGDET and MSRB meetings including preparatory activities
8. Interface with
the clinical team for safety matters including follow-up on events of interest
and input into site queries regarding adverse events, updating on PVO requirements
9. Lead the
training and mentoring of internal and cross-functional team members
Minimum
requirements Bachelor
of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant
field or Medical Degree (MBBS or MD) required. Medical degree is essential for
associates performing medical review of single case reports. Good
knowledge/fluency in English. Knowledge of other languages desirable. Bachelor
of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant
field or MD Languages: Good knowledge/fluency in English.
Knowledge of other
languages desirable. Experience/Professional requirement:
• May be a first
job in the pharmaceutical industry for an MD with 3or more years of clinical
experience after graduating from medical school
• 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
• Strong organizational and project management
skills
• Strong
negotiation and communication skills, and the ability to operate effectively in
an international environment
• Excellent
understanding of physiology, pharmacology, clinical study objectives, and the
drug development process
• Strong technical
and problem solving skills
• Good
presentation skills
• Strong computer
skills including, but not limited to, creation of spreadsheets, templates,
presentations and working with safety databases/applications.
• Ability to work
independently, under pressure, demonstrating initiative and flexibility through
effective innovative leadership ability.
• Ability to
mentor, and coach within IMS and cross functionally
• Ability to lead
global work groups
• Ability to lead
and deliver initiatives
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