Title:  Manager - 1

Job Title:

Manager - Risk Management Plans (RMPs)

Business Unit:

Global Pharmacovigilance

Job Grade

G10

Location:

Gurugram

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Profile

• Preparation and review of Risk Management Plans (RMPs) and Direct Healthcare Professional Communication (DHPC) letters in alignment with global regulatory requirements
• Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
• Development of Health Hazard Analysis (HHA) documents, including comprehensive risk evaluation
• Expertise in risk characterization, including identification, evaluation, and documentation of the risks
• Analysis of Individual Case Safety Reports (ICSRs) within aggregate contexts, assessing seriousness, expectedness, and causality, and integrating findings into cumulative safety profiles for molecules
• Systematic review of published scientific literature to support safety evaluation in RMPs
• Active participation in pharmacovigilance projects, including collation and preparation of responses to regulatory authority assessment reports

Competencies Required:                                                                                                                                                                                           

• Proficiency in causality assessment, MedDRA coding, and technical scientific writing, with hands-on experience in preparing Safety sections (Part II, part III & Part V) of Risk Management Plans (RMPs)

• Analysis of Individual Case Safety Reports (ICSRs) within aggregate contexts to perform benefit risk evaluation   

        Knowledge on preparation of Health Hazard Analysis (HHA) documents

Job Requirements

Educational Qualification –

BDS or MDS

Experience –

Tenure:  8+Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).