Pharmacy Supervisor - Mumbai - Doctors Without
- Doctors Without
- 2 - 3 years
- Mumbai
- 3 years ago
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Job Description
Vacancy:Pharmacy Supervisor (EndTb Trial)
Doctors Without Borders India
Doctors Without Borders/ Medecins Sans Frontieres (MSF) is an international,
independent, medical humanitarian organisation that delivers emergency aid to people
affected by armed conflict, epidemics, natural and man-made disasters and exclusionfrom
healthcare in more than 70 countries. DWB offers assistance to people in need and
irrespective of race, religion, gender or political affiliation.
Doctors Without Borders has worked in India since 1999, providing free-of-charge essential
healthcare to people in remote areas; treatment and care for people affected by HIV/AIDS,
malnutrition; hepatitis C, tuberculosis, kala azar and sexual and gender-based violence; an
important subject for our action is containing effect of antibiotic resistance. We also
respond to natural disasters and other emergencies, provides mental healthcare and
advocates for the development of more effective and affordable medicines to improve
access to treatment everywhere.
Doctors without Borders was awarded the Indira Gandhi Prize for Peace, Disarmament and
Development in 1996 and the Nobel Peace Prize in 1999.
Doctor without Borders India (DWBI) runs projects in the states of Andhra Pradesh, Bihar,
Chhattisgarh, Delhi, Jammu and Kashmir, Jharkhand,Maharashtra,Manipur,andTelangana.
Doctors Without Borders India (DWBI) and the endTB project
Doctors Without Borders, and its partners i.e. Partners In Health (PIH), Interactive Research
and Development (IRD), Epicentre, France, Institute of Tropical Medicine, Belgium and the
Harvard Medical School have launched two major clinical trials, endTB and endTB-Q which
seek to revolutionize treatment for the toughest strains of tuberculosis (TB), the worlds
leading infectious disease killer. The goal of these studies is to generate high quality
evidence from a highly heterogeneous population that could lead to a change in the global
recommendations for the management of MDR-TB.
The endTB trials are multi-country, randomized, controlled, Phase III clinicaltrial testing five
new, all oral, shorter duration regimens compared to the current standard of care. The aim
of the trials is to find shorter, less toxic and injection-free treatments for multidrug-
resistant TB (MDR-TB). The experimental regimens mainly rely on newly approved or
repurposed drugs and avoid drugs to which high rates of resistance have been reported in
MDR-TB patient populations.These multi-country trials are being conducted in
Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa and Vietnam. InIndia the
trials are conducted at Mumbai and Pune sites by Doctors Without Borders India (DWBI) in
Partnership with ICMR- National AIDS Research Institute (NARI) and in support with
National Tuberculosis Elimination Program (NTEP).
Benefits (Non-negotiable)
Monthly Gross Salary: INR 46,368/- and Secondary Benefits as per policies:
13th Month Salary/ Festival Bonus
18 Annual Leaves
12 Casual Leaves
Other compassionate leaves
Medical Reimbursement including dependents
Personal Accidental Insurance including dependents
Specific skills
Ability to organize and prioritize workload & taking initiative when
appropriate
Able to integrate into a multi-cultural team andcooperatewith co-workers
Able to work independently as well as part of a team and ability to cope
with stress.
Good Punctuality and ability to act with responsibility
Demonstrates flexibility in taking up tasks outside of regular job
responsibilities as required and aptitude for humanitarian medical work.
Excellent computer skills (especially MS Office MS Word and MS Excel) &
reporting skills.
Languages: English, Hindi & Marathi.
To apply please email your CV and motivation letter with the subject Ref:
Pharmacy Supervisor
To: ms**********i@br*****s.msf.org by 17th November 2020 5:00 pm.
ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW.
www.msfindia.in Main Tasks & Responsibilities
Pharmacy Regulatory Compliance
Ensure that all study drugs are stored according to protocol/SOP/manufacturers instructions and Indian
Good Pharmacy Practice (GPP) in restricted access area to prevent loss or use by unauthorised individuals.
Maintain pharmacy temperature and humidity conditions and continuous monitoring, in accordance with
trial SOPs.
Supervise pharmacy quality assurance and quality control processes.
Complete and maintain pharmacy records for the Sponsor and regulatory audits, in accordance with Good
Clinical Practice (GCP) and GPP.
Assist monitors in drug accountability visits
Assist the endTB Medical Activity Manager with registration of the pharmacy and submissions of all
pharmacy related documents to DCGI
Investigational Product
Assist with procurement of trial medication.
Receive trial drugs from suppliers; document receipt and resolve discrepancies.
Maintain accurate and proper records for all drugs received and distributed, according to trial SOPs.
Verify investigator or designee has obtained informed consent from the patient.
Supervise and assist with the preparation of medication blister packs for participants as per prescriptions
from trial doctors, in accordance with the trial SOPs
Supervise and assist with the labeling of trial medication before dispensing, in accordance with trial SOPs
Supervise and assist with the dispensing of trial medication, as per specific protocol/SOP requirements
Supervise and assist with the counselling and education of patients on drug administration, side effects,and
adherence. Receive and reconcile IP returns.
Assist with pill counts and adherence monitoring.
Return and/or properly dispose of trial drugs as per protocol/SOP.
Maintain stock control and a record of dispensed medication, according to trial SOPs
Record Management
Maintain IP accountability records.
Maintain prescription records against which IP is dispensed and pharmacy sections of the Site Master File
Communication
Communicate with trial medical officers, nurses, and Sponsor when needed.
Attend meetings related to the endTB trial, including at MSF, and community forums. Other
Overall management and oversight of the endTB trial Pharmacy activities
Manage, supervise and support the role, responsibilities and day-to-day activities of the trial pharmacy
assistants, (including but not limited to training, performance evaluation, development and internal
communication).
Comply with all aspects of the Mission, Project and Trial Standard Operating Procedures
Provide technical and back-up support to the Project pharmacy assistant
Pharmacy Supervisor will be required to ensure that the activities performed in the clinical trials are inline with
the protocols, the regulations and that the study documentation is of quality and compliant with the trial
framework.
Qualifications:
Essential: Degree in Pharmacy Registered with the State Pharmacy Council
Desirable; Masters degree in Pharmacy
Experience: Minimum of 3-4 years of experience in clinical trial
Working on MDR-TB patient clinical documents (advantage)
GCP certificate Experience and GPP training (advantageous)
Computer proficiency in MS Excel and Word
Previous experience in TB and/or HIV information management is an asset.
Duration 12 Months (Renewable)
Location: Mumbai ((Sarvodaya Hospital, Ghatkopar)
Expected Start Date: 1ST December 2020.
Job Classification
Industry: NGO, Social Services, Regulators, Industry AssociationsFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Medical Professional
Role: Medical Professional
Employement Type: Full time
Education
Under Graduation: B.Pharma in PharmacyPost Graduation: M.Pharma in Pharmacy
Doctorate: Doctorate Not Required
Contact Details:
Company: Doctors WithoutAddress: 3RD FLOOR, PITRUCHAYA, SANGHAVI CORPORATE PARK, NEAR WASAN MOTORS, GOVANDI EAST, MUMBAI - 88
Location(s): Mumbai
Keyskills: Regulatory Audits Dispensing Pharmacy Practice Pharmacovigilance Clinical Trials Medicine Clinical Research Continuous Monitoring Pharmacy Healthcare Quality Assurance Standard Operating Procedures Supervision Quality Control
Doctors Without
Médecins Sans Frontières (MSF)/Doctors Without Borders is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, natural and man-made disasters and exclusion from healthcare in more than 65 countries...
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