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Premium Employer

Sandoz

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4.0

based on 390 Reviews

409 Sandoz Jobs

Medical Safety Lead

Sandoz

4.0

based on 390 Reviews

4-8 years

Hyderabad / Secunderabad

1 vacancy

Medical Safety Lead

Sandoz

posted 6hr ago

Job Role Insights

Flexible timing

Key skills for the job

Medical Coding Pharmacy Pharmacovigilance Nursing Clinical Data Management Risk Management

+ 4 more

Job Description

Your responsibilities include, but not limited to:

Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs).
Preparation/review of investigator notifications and periodic medical assessments for ethics committees
Medical review of single case reports according to business needs (example SUSARs)
Review safety documents prepared by External Service Providers.
Performs medical assessment of product quality defects with or without adverse events, including the review of line listings whenever required and proposes relevant market action.
Monitoring and evaluation of all safety signals both from internal and external sources including literature sources, single cases and/or aggregate data and presents the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed.
Prepares safety responses to inquiries from regulatory authorities, health care professionals or legal queries on the benefit-risk balance of assigned products. Supports Country Organization and other stakeholders on safety related questions when global input is required.
Depending on assigned products and portfolio, may support the GPSL/Medical Safety Group Lead and the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents. In this context, the Medical Safety Lead may deputize for the Senior Medical Safety Lead for the preparation of safety documents (e.g. summary of clinical safety, clinical overview) for review by GPSL.
Lead/Review the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels.
Provides guidance as appropriate to Case processing team for the coding and causality/expectedness assessment of adverse event reports as and when needed.
Provides inputs and collaborates on preparation of Safety Profiling Plan (SPP).
Provides safety inputs for clinical and regulatory deliverables including but not limited to clinical study protocols (e.g. - PASS, consortia studies etc.), clinical study reports, investigator brochure and safety management plans.
Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, and other related departments Provides relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed depending upon the portfolio and products assigned.
Provides support as needed for regulatory authority inspections and internal/external audits. Perform Root cause analysis (RCA) and propose robust Corrective and Preventive Actions (CAPA) as appropriate.
Provides support as needed for licensing activities. Leads the safety review for due diligences/mergers and acquisitions and proposes relevant action/mitigation strategies.
Provide safety input for Post marketing surveillance plans, Clinical Evaluation Plan and
Report (CEP/CER) and other safety related documents in the context of EU Medical Device Regulations.
Preparation and review of working instructions and procedures.
Perform tasks as per assigned workstreams.

What you ll bring to the role:

Essential Requirements:

Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required.
Medical degree with specialization preferred
Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.
Fluent English knowledge in spoken and written
Relevant experience (e.g., clinical, postdoctoral) after graduation.
At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience) is desirable.
Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports involving safety information
Experience with (safety or others) issue management and decision making on safety topics.

You ll receive:

Sandoz has an employee-first approach and that s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

30 days of annual leave
Holiday allowance
Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
Company pension schemes and capital formation benefits
Parental leave
Other offerings, such as bike leasing

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here: https: / / talentnetwork.novartis.com / sandoztalentpool

Skills Desired

Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Science

Employment Type: Full Time, Permanent

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