Genpact MSc Life Sciences Job – Labelling and Safety Manager Post
Genpact is a global professional services firm with a startup spirit and over 115,000 passionate and curious minds. We partner with some of the world’s biggest brands, harnessing technology and humanity to drive meaningful transformation. As we continue on our relentless pursuit of better, we are seeking thinkers and doers who are hungry to learn and make an impact. If you thrive on experimentation, embracing opportunities, and pushing boundaries, join us in creating a better world while building your own intellectual firepower.
Responsibilities:
As the Labelling and Safety – Pharmanovia Manager, you will be responsible for the following activities in a highly regulated and process driven environment:
- Regulatory review of CCDS updates
- Gap analysis review of country level Product Information (PI)
- Defining regulatory strategy and definition
- Listing and collection of local administrative requirements for variations
- Cross-functional work with PV and Artwork department for submission preparations
- Safety submissions related to PRAC Update, CCDS, PADER, and PSUR
- Drafting responses to MAH for Health Authority queries
- Compilation of local requirements supported by representatives and partners
- Identifying discrepancies/issues in local implementation of corporate labels
- Monitoring reference labels for updates and communication with concerned affiliates
- Maintaining updates related to labeling guidelines and regulations
- Evaluating Change Controls and performing Impact Assessment
- Authoring and submitting safety variations to regulated and non-regulated markets
Requirements:
To be considered for this role, you should have the following qualifications:
- Masters in Lifesciences or equivalent with proven regulatory Affairs/Labeling experience
- Effective communication, time management, organizational skills, and troubleshooting attitude
- Knowledge of labeling principles and concepts related to HMA and EMA
- Familiarity with international legislation, guidelines, and customer practices on Signal detection
- Ability to identify discrepancies/issues in local corporate label implementation
- Construction of Company Response (MAH response) for health authority questions
- Preferred qualifications: Excellent communication and PC skills
Qualifications we seek in you:
- Minimum Qualifications: Pharmacy/Science
- Preferred Qualifications/ Skills
Location: Mumbai
Shift: UK Shift (12.30 pm-9.00 pm)
Genpact is an Equal Opportunity Employer committed to diversity and inclusion. We value respect, integrity, customer focus, and innovation. We do not charge fees for job applications, and applicants are not required to pay to participate in our hiring process. Please be aware of any scams that may request payment for job applications or training.
Keywords: Genpact, safety, labelling, Pharmanovia, manager, MSc Life Sciences, regulatory affairs, labeling, PRAC, CCDS, PADER, PSUR, healthcare, pharmaceutical industry. Genpact MSc Life Sciences Job – Labelling and Safety Manager Post. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
