Associate - Regulatory Affair
- Genpact India
- 1 to 2 Yrs
- Mumbai
- 5 years ago
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Job Description
*With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Are you the one we are looking for
We are inviting applications for the role of Associate, Regulatory affairs In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
Responsibilities
The Role demands for a highly qualified professional who should have Regulatory Data safety experience under regulatory affairs domain. Associate will be responsible for activities related to
Preparing and sorting documents for safety data entry.
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
Entering data into database software and checking to ensure the accuracy of the safety data that has been entered in the software within the established timeframes.
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and supervising incoming - Adverse Events(AE)/endpoint information
Resolving initial/update status of incoming events
Resolving discrepancies in information and acquiring further information for incomplete documents.
Crafting, maintaining and tracking cases as applicable to the project plan.
Through daily case prioritization activities, reports are completed within the established timeframes to ensure compliance with internal, business partner, and regulatory agency reporting requirements worldwide.
Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines
Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files)
Preparation and sending of follow up requests
The ICSR search/retrieval process from the EVWEB database and company/non-company assessment for cases
Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers
Classification of references of safety-relevant publications
Data entry of literature reports into the safety database
Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files)
Downloading, reviewing and sharing of client specific ICSRs from MLM service of EMA
Coding of the events/drugs using MedDRA/CCDS .
Minimum Qualifications
Bachelor s degree in pharma / Science
Strong financial analytical skills and problem solving skills.
Effective communicate in writing and verbally to senior management.
Experience in balancing customer facing role and work assessments.
Self-starter and have analytical, prioritization skills
Ability to balance customer governance meetings
Preferred qualifications
Able to further working relationships with the team, peers and clients, scheduling flexibility required
Overall candidate should have decision-making, research and analytics approach and in numbers.
Good people and customer handling skills.
Effective communication and interpersonal skill.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube.
,Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: Associate - Regulatory AffairContact Details:
Company: Genpact IndiaLocation(s): Mumbai
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