Panacea Biotec
is a leading research based Health Management
Company, with an annual turnover of approx. Rs. 800 Crores. We
are engaged in research, development, manufacture & marketing of
Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of
international quality and Health Services. All Panacea Biotec
plants are accredited by international agencies and they follow
current Good Manufacturing Practices, as per WHO guidelines.
We offer stimulating work environment & a career that spells
growth. In tune with our plans, we require young, aggressive,
dynamic, high performing and result oriented professional.
Designation
Analyst - Pharmaco
vigilance
Job Description
Role & responsibility:
1) Receiving and processing literature searches and
subsequent ADRs
2) Enter and QC ADR information into the database
3) Update ADR tracker with new information, write ADR
narratives, report ADRs to regulatory authorities
4) Follow up with physicians and healthcare
professionals regarding ADRs
5) Prepare annual safety reviews for products and
maintain a good knowledge of current pharmacovigilance
legislations and SOPs.
6) Develop appropriate understanding of DSS case
processing, required DSS and company SOPs, coding
conventions, etc.
7) Develop expert technical understanding of the
relational design and structure of the corporate safety
database and data variable definitions, as well as
similar information in other safety data sets, such as
those from clinical trials.
8) Report generation and authoring includes sections
that PVRM is responsible for in regulatory reports,
ad-hoc requests from regulators, requests from key
stakeholders, such as Clinical Research.
9) Assist in developing routine and non-routine PVRM
evaluations of safety data by developing reports from a
variety of data sources, including the corporate safety
database and safety data from ABPs, and author a
preliminary report describing methodology and factual
summaries of output to assist the medical resources in
their evaluation of routine and non-routine reports,
events of interest, and evaluation of potential signals.
Desired Profile
Skills/ Competencies:
1) Excellent written and verbal communication skills; A
good knowledge of pharmacology as well as an interest in
medical, pharmaceutical or scientific subjects in also
required.
Experience
3 - 5 Years
Industry Type
Pharma/ Biotech/Clinical
Research
Functional Area
Healthcare, Medical, R&D
Education
UG - B.Pharma -
Pharmacy;MBBS - Medicine;Other Graduate - Any
Specialization