Manager-Regulatory Affairs - Synowledge PV Services India Pvt Ltd

By: Pharma Jobs | Views: 12001 | Date: 24-Jun-2011

Synowledge specializes in providing drug safety and pharmacovigilance services to small, mid and large size pharmaceutical and biotechnology companies. Our team consists of highly qualified and skilled experts (MDs, PhDs and other individuals with Life Science backgrounds and PV experience) who are committed to helping life sciences companies meet and exceed their challenging demands of a critical component of safety reporting. Synowledge’s broad range of solutions include call center (includes handling of

 
Experience:

5 - 8 Years

Location:

Bengaluru/Bangalore

Compensation:

Rupees 8,00,000 - 18,00,000

Education:

UG - B.Pharma - Pharmacy,MBBS - Medicine PG - Any PG Course - Any Specialization,Post Graduation Not Required

Industry Type:

KPO / Research /Analytics

Role:

Regulatory Affairs Mgr

Functional Area:

Healthcare, Medical, R&D

Posted Date:

24 Jun

Desired Candidate Profile

EDUCATION & EXPERIENCE:

o A degree in Pharmacy or medicine with affiliations with RAPS or TOPRA or masters degree in Pharmacy

o 5 to 8 years of hands-on experience across the range of services offerred by Synowledge (listed above)

Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:

o Keep up to date with market trends and new developments utilizing information for process and service improvements

o Team Management

o Project Management

o Ability to understand the requirement from the client and arrive at a possible solution that is cost effective while ensuring regulatory compliance

SPECIALIZED KNOWLEDGE AND SKILLS:

o Affiliation with TOPRA or RAPS

o Skilled to build team and capabilities from scratch

COMMUNICATION SKILLS:

Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross-department communication. Ability to document and communicate problem/resolution and information/action plans.

TECHNICAL SKILLS:

In depth subject knowledge and hands on experience in at least 10 of the following service offerings:

o Product Development & Regulatory Strategies

o Regulatory Submissions & Meetings

o Operations, QA & QC Support

o Compliance Audits & Training

o Drug Safety Regulatory Services:

o Reviewing and Assessing Clinical Protocols

o Reviewing Safety and Efficacy Related Issues During Product Development

o Adjudicating Clinical Data : Collect, collate and evaluate

o Global Regulatory Strategies

o CMC (Chemistry, Manufacturing, Control)

o Medical Writing

o Labeling and updates

o Translations of Technical Documents: all official European languages through effective network of regulatory consultants.

o Coordination of Regulatory Certificates

o Regulatory Maintenance of Older Products

o Labeling Updates and Harmonization of Labels

o Coordination of Regulatory Certificates

o Dossier preparation for Medical Devices

o Dossier writing: registering the products in worldwide markets like EU, USA and ROW countries in CTD format and as per country specific guidelines for any dosage form. Evaluate Dossier if procured for submission in EU or for product development

o Labeling for Medical Devices

o Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.

o Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale

OTHER SKILLS:

NA

EDUCATION & EXPERIENCE:

o A degree in Pharmacy or medicine with affiliations with RAPS or TOPRA or masters degree in Pharmacy

o 5 to 8 years of hands-on experience across the range of services offerred by Synowledge (listed above)

WORKING CONDITIONS:

Normal office environment. Ability to work under stress and tight deadlines.

 

Keywords: Drug Safety Regulatory Services, Dossier preparation for Medical Devices, oDossier writing: registering the products in worldwide markets like EU, USA and ROW countries in CTD format
 

Company Profile

Synowledge specializes in providing drug safety and pharmacovigilance services to small, mid and large size pharmaceutical and biotechnology companies. Our team consists of highly qualified and skilled experts (MDs, PhDs and other individuals with Life Science backgrounds and PV experience) who are committed to helping life sciences companies meet and exceed their challenging demands of a critical component of safety reporting. Synowledge’s broad range of solutions include call center (includes handling of medical inquires and product complaints and processing of medical inquiry calls), case intake and data entry, coding, expert medical triaging of adverse event cases, generation of expedited and periodic reports, Qualified Person for Pharmacovigilance (QPPV) services and overall analysis and trending of cases (signal detection).
Contact Details
Company Name:

Synowledge PV Services India Pvt Ltd

Executive Name:

Jayasudha Puttaswamy

Address:

Not Mentioned

Telephone:

Not Mentioned

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