30 January, 2016
Exp. 8 – 13 Years Â Â Â Â Â Â Location: Bengaluru/Bangalore Â Â Â Â Â Â Openings: 2
We at Accenture are looking out for professionals for our PV Team.
Location: Bangalore – Permanent
Role: Data Safety Associate Manager
ACCENTURE: Accenture plc is a multinational management consulting, technology services, and outsourcing company. It is the world’s largest consulting firm as measured by revenues and is a Fortune Global 500 company. Accenture’s current clients include 89 of the Fortune Global 100 and more than three-quarters of the Fortune Global 500.
Overall Purpose of the job
* Ensure timeliness and quality of serious and non-serious AESI case processing from data entry to approval as per regulatory and client requirements.
* Ensure timelines and quality of seriousness check team in compliance with UCB business rules, standard operating procedures and global regulatory requirements. Provide guidance and support to the team members to perform their job roles effectively thereby achieving the service level agreements. Ensure incoming safety information is handled as per regulatory and client requirements.
* Overall responsibility of serious and non-serious AESI case processing and evaluation/approval of cases.
* Ensure timelines and quality of seriousness check team in compliance with client DS business rules, standard operating procedures and global regulatory requirements.
* Ensure all case reports are processed by the team members as per regulatory timelines, service level agreements and client SOPs, conventions and other guidelines, as applicable.
* Ensure all the team members are updated on any change in regulatory requirements or client SOPs, guidelines and conventions for case processing.
* Oversee internal quality checks at case processing and approval by the team leads.
* Analyze the errors identified in quality checks, identify the root cause, formulate and implement corrective and preventive action.
* Ensure appropriate query has been raised to obtain additional information/clarification that would be necessary for the accuracy and/or completeness of the individual case safety report.
* Oversee work flow management from case creation to approval.
* Provide feedback from the case approval team to case processing team.
* Ensure consistency of approach across teams in case processing and approval.
* Resource Management
* People Management
Educational and Experience Requirements :
Qualification – MBBS – MUST
Good to have 4 -5 years minimum experience in single case processing.
Thorough knowledge of medical terminology.
Good experience in pharmaceutical industry (Pharmacovigilance, clinical research, medical affairs, medical writing, etc.) preferred.
Good communication and team management experience.
If interested kindly share your updated CV and fill in the below details:
Total experience in pharmaceutical:
Total experience in Pharmacovigilance:
Total experience in single case processing:
Current CTC(Fixed & Variable)
Salary: Not Disclosed by Recruiter
Industry: BPO / Call Centre / ITES
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Director
Role: Drug Regulatory Director
PG – Any Postgraduate – Any Specialization, Post Graduation Not Required
Doctorate – Any Doctorate – Any Specialization, Doctorate Not Required
Accenture is a global management consulting, technology services and outsourcing company, with more than 323,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$30.0 billion for the fiscal year ended Aug. 31, 2014. Its home page is www.accenture.com.
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