Title:  Sr.Exe/ Manager 2-Global Pharmacovigilance

Job Title:

Sr.Exe/ Manager 2

Business Unit:

Global Pharmacovigilance

Job Grade

G11B/A

Location:

Mumbai

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.”

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Job Profile:

• Evaluate incoming communication for potential adverse event reports via local intake system, phone, fax, mail, social media and other methods in the database.
• Medically evaluate and processes adverse event reports daily from the database for possibility of seriousness and expedited reporting to FDA and Health Canada.
• Reports cases to the proper regulatory authority within the required reporting period, as needed.
• Process daily queries and provides response within the same business day.
• Process literature cases as needed and maintains literature report spreadsheet.
• Provide AE Case follow up and maintains report spreadsheet.
• Ensure receipt of adverse events from Marketing programs.
• Support internal audits and external inspections.
• Perform trending for adverse event reporting by preparing quarterly reports.
• Prepare Annual Summary report for drug products marketed in Canada.
• Perform reconciliations for Product Quality complaints and reports involving partners.
• Conduct monthly Health Canada Adverse event search in the Vigilance database.
• Other duties, as needed.

Competencies Required:

Ability to demonstrate working knowledge of FDA and Health Canada guidelines for post-marketing drug and medical device safety surveillance.

• Working knowledge of medical terminology and MedDRA. Must be familiar with a Drug Safety database e.g. Wilke database, Argus.

• Strong knowledge of MS Office (Word, Excel, PowerPoint)

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Ability to multi-task under pressure.

• Ability to read, analyze, and interpret common scientific and technical journals

Job Requirements

Educational Qualification –

BDS/MDS/M.Pharma in Healthcare, Science discipline, or applicable healthcare education/certifications (i.e., RN, pharmacist),

Experience –

Tenure:  5+ 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).