Clinical Research Associate - Mumbai-Siro Clinpharm Pvt. Ltd.

Job Description

 

Site Monitoring

To ensure all relevant studies follow SIRO/applicable SOPs, GCP and local regulations.

To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current.

In coordination with the project manager, perform study site selection and qualification visits. Also to participate in/conduct investigators meeting and site initiation visits.

To identify, define, coordinate and conduct site study training.

In coordination with the project manager, provide oversight of all study-related activities.

To perform regular monitoring visits to site

To prepare monitoring reports.

To maintain audit readiness at the site level.

To ensure that the clinical trial supplies are appropriately handled and adequately maintained at the site as per the project requirements.

To ensure site level metrics (i.e. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate

Issue Resolution

Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level.

Ensure proper escalation of site/project related issues

. Intervention and Coaching

. Teamwork

Liaison with Other Departments 

 

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Pharmovigilance Scientist-Novartis Healthcare Pvt. Ltd.

Job Description

 

1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality. 2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms. 3. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed. 4. Determine the necessity for follow-up and prepare follow-up request as needed.

1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality. 2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms. 3. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed. 4. Determine the necessity for follow-up and prepare follow-up request as needed. 5. Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased. 6. Triage literature cases for databasing or pass them on to the Team Leader for approval of rejection. 7. Co-author, together with the Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data. 8. Work with external partner groups, e.g. co-licensing partners and ClinicalResearch Organisations to meet joint accountabilities 9. Represent DS&E at internal and external meetings 10. Assist the Medical Safety Physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports. 11. Assist the Medical Safety Physicians in monitoring the safety profile of product 12. Be involved in development and testing of safety systems/IT applications and in the preparation of relevant manuals. 13. Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs Impact on the organization: Ensure that Serious Adverse Event / Post Marketing Adverse Event are evaluated accurately and within the required timeframes to meet regulatory requirements Alert the Medical Safety Physicians to potential safety issues. 

 

Desired Candidate Profile

Education-

UG: B.Sc - Nursing
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Doctorate Not Required

Minimum requirements:
Life sciences degree / Nursing background Good knowledge/fluency in English. Knowledge of other languages desirable. Experience in drug safety / Development or closely related areas of responsibility Experience of safety document writing Good negotiation and oral communication skill.

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Walk - In Interview in Quintiles on 6th June 2015

Job Description

- 2,00,000 - 7,00,000 P.A 

 

Walkin Interview in Quintiles on 6th June 2015.

Desired Profile:-
Clinical Research Professionals - Looking for candidates with 1 - 7 years of clinical research experience , CRA, CTA, CPC, Research Professionals, Scientist are all welcome.

Clinical Project Co - ordinators - Looking for  candidates with 1+ years in clinical research.

Line Managers: Looking for Candidates with 6 + years of experience in supervisory roles in Clinical / Pharma/ Healthcare domain.

Trainers - Looking for Candidates with 6+years of training experience in clinical domain

Date: June 6th , Registration Time : 8.00AM - 9.30AM
Venue: Quintiles,
Wing A, Etamin Block, Prestige Tech Park
Sarjapur - Marathalli , Outer Ring Road.
Bangalore: 560103

 

Quality Control Specialist- Publications-Cactus Communications

Job Description

 

The medical writing team at CACTUS works with multinational pharmaceutical companies, clinical research organizations, and researchers worldwide to help them communicate their science. We are currently looking to add to our team, an experienced QC specialist who wishes to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.

As part of his/her key responsibilities, the QC specialist at CACTUS will

• Fact check manuscripts, posters, slide decks, educational material, medical literature, etc, provided by clients for data accuracy
• Check documents (mentioned above) developed by medical writers for scientific data errors by checking the developed material against annotated references, CSRs, other source data 
• Check for discrepancy within text, discrepancy between figures/tables, and between text and supplementary material
• Identify missing sources documents and gaps in scientific logic 
• Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements
• Be responsible for the quality of the documents/projects fact checked/QCed
• Ensure effective communication of QC/fact check findings with the client/medical writers 
• Deliver QC reports to the stakeholders, and identify quality trends
• Ensure 100% timely delivery of documents

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy, BHM - Hotel Management, B.Sc - Any Specialization
PG:M.Sc - Any Specialization
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

This position requires:


• Minimum 2 years of experience in the medical writing industry; freshers with substantial knowledge of the publication landscape and with published papers are also eligible
• PhD or Masters degree in Research, or equivalent industry experience
• Ability to work efficiently and independently, multitask, and prioritize
• Excellent attention to detail, and zero tolerance to errors
• Ability to concentrate and work under pressure and meet tight deadlines
• Excellent written and oral communication skills 
• Functional with Microsoft Word, Excel, and PowerPoint
• Flexible and adaptable to changing project priorities and work assignments

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Global Medical Affairs Manager role with US Pharma MNC

15,00,000 - 22,50,000 P.A 

Job Description

 

1) Responsible for providing medical and scientific expertise for the support of EPD products including regulatory and safety documents; advertising and promotional review; and global medical information.
2) Serves as a conduit and facilitator of communication between Medical Affairs and Commercial, Global PV, Global Regulatory, and affiliate medical departments with respect to assigned brands.
3) Provides training to affiliates and other colleagues on medical information and medical review skills to support their business objectives. 

 

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy, MBBS - Medicine
PG:M.Pharma - Pharmacy, M.S/M.D - Any Specialization
Doctorate:Doctorate Not Required, Ph.D - Advertising/Mass Communication, Medicine, Pharmacy, Other Science

 1) Minimum of 4 years of combined licensed clinical practice experience, postgraduate training, and/or postgraduate pharmaceutical industry experience.
2) Strong clinical reasoning skills, with the ability to independently assess and conclude on published and in-house data related to pharmaceutical products and EPDs therapeutic areas
3) Needs to be able to think strategically and demonstrate ability to make effective decisions based on good science and data in compliance with regulatory requirements; can comfortably handle risk assessment and uncertainty.
4) Basic knowledge of industry trends and processes, clinical data, statistical concepts, and regulatory requirements to provide scientific and clinical support of pharmaceutical products.
5) Strong writing skills are required.
6) Successful project management experience required. 

 

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Senior Medical Writer/ Junior Medical Writer (1-4 yrs)-Openings: 3-Digital A Plus Group

Job Description

 

Develop scientific medical content. meeting international quality standards. Development of medical e-learning modules, brochures, e-detailers, websites, apps, MOAs, teasers, manuscripts, articles, TOCs, Interface with clients on a regular basis. 

 

Desired Candidate Profile

Education-

UG: B.Pharma - Pharmacy, MBBS - Medicine, BDS - Dentistry
PG:Post Graduation Not Required, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required

Min 1 to 4 yrs of experience in pharmaceutical companies in any of the following functions-medical services/ medico-marketing / regulatory affairs or in medical writing/ developing/ publishing medical content. Strong written and verbal communication.

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