Drug Safety Associate

4 days ago

Hyderabad, Telangana, India Vizen Life Sciences Full time

Key Responsibilities:

  • Authoring and Reviewing PSURs and RMPs

Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs) for submission to health authorities.

Ensure the accuracy, completeness, and regulatory compliance of all PSURs and RMPs.

  • Literature Search and Validation

Perform literature searches to gather relevant data for PSUR and RMP preparation.

Validate the information obtained from literature searches to ensure accuracy.

  • Data Management

Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP).

Generate Line Listings (LL) from the safety database for inclusion in PSURs.

  • Process Management

Manage and reconcile relevant process trackers to ensure all activities are documented and on schedule.

Provide reliable support for high-priority ad-hoc activities related to PSUR preparation.

  • Client Interaction

Communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies.

Ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines.

  • Subject Matter Expertise and Training

Serve as a subject matter expert (SME) for PSUR preparation and review.

Provide training and mentoring to team members on PSUR-related processes and regulatory requirements.

Qualifications:

  • Bachelor's degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred.
  • Experience in pharmacovigilance, drug safety, or related field, with a focus on PSUR preparation and review.
  • Knowledge of regulatory requirements for PSURs/PBRERs.
  • Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data.
  • Excellent written and verbal communication skills.
  • Proficiency in safety databases and data extraction/validation processes.
  • Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
  • Demonstrated ability to collaborate effectively with cross-functional teams and provide expert

  • Patient Safety Associate I

    6 days ago

    Hyderabad, Telangana, India Parexel Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Patient Safety Associate I

    6 days ago

    Hyderabad, Telangana, India Parexel Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Consultant - Vault Safety

    2 days ago

    Hyderabad, Telangana, India Veeva Systems Full time

    Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead.At the heart of Veeva are our values: Do the Right Thing, Customer...

  • Associate Director, Safety Enablement

    1 week ago

    Hyderabad, Telangana, India Johnson & Johnson Innovative Medicine Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Senior Research Associate

    2 days ago

    Hyderabad, Telangana, India AVEVA DRUG DELIVERY SYSTEMS INC Full time

    Job Details Job Location:    Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA Salary Range:    Undisclosed Job Shift:    Day DescriptionResponsible for execution of Analytical Method Transfer / Analytical Method Validation / Analytical Method verification / Analytical method feasibility activities / other activities for drug substance / drug...

  • Senior Global Program Safety Team Lead

    6 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 15,00,000 - ₹ 30,00,000 per year

    Job Description SummaryThe Sr. GPSL-TL serves as strategic leader of the Medical Safety organization to improve patients' lives and impact on overall Novartis results through robust safety risk management. This role requires an experienced and knowledgeable safety clinician responsible to predict safety risks and assess scientific information to guide the...

  • Senior Global Program Safety Team Lead

    4 days ago

    Hyderabad, Telangana, India Novartis Full time

    SummaryThe Sr. GPSL-TL serves as strategic leader of the Medical Safety organization to improve patients' lives and impact on overall Novartis results through robust safety risk management. This role requires an experienced and knowledgeable safety clinician responsible to predict safety risks and assess scientific information to guide the assigned teams on...

  • Head Medical Safety Process

    6 days ago

    Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job Description SummaryProviding leadership, oversight and expertise with respect to Processes, Procedures (includinginvolvement of appropriate systems) and Projects relevant for Medical Safety. Responsible for drivingand/or facilitating process developments / improvements (incl. simplifications) considering external aswell as internal needs. Strategically...

  • Associate Director

    2 weeks ago

    Hyderabad, Telangana, India Syneos Health Full time ₹ 10,00,000 - ₹ 18,00,000 per year

    Associate DirectorSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  Our Clinical Development model brings the customer and the patient to the center of everything...

  • Medical Safety Processes and Projects Manager

    4 days ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description SummaryThis role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities. Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Manager is responsible for planning of deliverables associated with MS owned processes and...