RMP Manager
- The Medicines Company
- 5 - 8 Years
- Hyderabad
- 5 years ago
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Job Description
70! approved Risk Management Plans (RMP) in Novartis for originator products and many more to come. That's the number of RMPs we are responsible for - from creation to implementation. Safety Risk Detection and Management (SRDM) is a group within the global Patient Safety organization; we support safety physicians and the Global Products Team (GPT) to plan for, prepare and establish RMPs. We bring the key safety messages for the safety concerns to physicians and patients, and we help to identify
Your responsibilities include, but are not limited to:
End to end management of assigned pharmacovigilance processes across Novartis Divisions Responsible for ensuring compliance to global regulatory requirements with maximum efficiency
Lead assigned cross functional patient safety projects; Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally
Develop and maintain training material and communications for Novartis group and third party associates; Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements
Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases). Analyze the impact of other process and organizational changes
Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of actions taken
Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
Work jointly with other functions (like Compliance & Quality and Process Compliance & Risk Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any identified risks. Mentor and train new starters
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Minimum requirements
At least 5 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs.
Proven ability to work with large cross-functional teams in complex projects. Has demonstrated teamwork and effective communication skills. Works effectively and is able to establish relation- ships with other line functions.
Knowledge in worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.
Proven ability to interpret, discuss efficacy and safety data relating to multiple therapeutic areas.
Solid Medical/Scientific writing and verbal skills.
Education qualification- M. Pharma/PharmD/Ph.D. or BHMS, Dentist, BAMS, MBBS will also do.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Employement Category:
Employement Type: Full timeIndustry: Full timeFunctional Area: Not ApplicableRole Category: ManufacturingRole/Responsibilies: RMP ManagerContact Details:
Company: The Medicines CompanyLocation(s): Hyderabad+ View Contact
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