Associate Medical Safety Director
Company: IQVIA
Location: Thane, India (Home-Based / Remote)
Job Type: Full-Time
Job ID: R1532084
Department: Pharmacovigilance / Medical Safety
Experience Required: Minimum 5+ years of relevant experience including clinical practice and pharmaceutical industry exposure
Education: Medical Degree (MD/MBBS or equivalent) from an accredited and internationally recognized medical school
About IQVIA
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial insights for the life sciences industry. The organization supports pharmaceutical and biotechnology companies in accelerating the development, approval, and commercialization of innovative therapies that improve patient outcomes worldwide.
Through advanced data science, medical expertise, and integrated research capabilities, IQVIA enables healthcare organizations to make evidence-based decisions across the drug development lifecycle.
Job Overview
IQVIA is seeking an Associate Medical Safety Director to provide medical expertise in pharmacovigilance and drug safety across clinical trials and post-marketing safety programs. The role involves reviewing adverse event reports, overseeing safety data evaluation, supporting regulatory safety documentation, and contributing to benefit-risk assessments.
The Associate Medical Safety Director collaborates with pharmacovigilance teams, clinical teams, and regulatory stakeholders to ensure accurate safety monitoring, regulatory compliance, and timely safety reporting throughout the product lifecycle.
Key Responsibilities
Pharmacovigilance and Safety Review
Perform medical review and clarification of clinical trial adverse events (AEs) and post-marketing adverse drug reactions (ADRs).
Evaluate safety reports including narratives, coding accuracy, expectedness, seriousness, and causality assessments.
Provide medical oversight to ensure high-quality pharmacovigilance case processing and regulatory compliance.
Safety Data Analysis and Monitoring
Conduct aggregate reviews of safety information and clinical data to monitor product safety profiles.
Review coding of adverse events, medical histories, and concomitant medications to ensure clinical accuracy.
Contribute to benefit-risk evaluations and drug safety assessments.
Regulatory Safety Documentation
Provide medical review and editing for regulatory safety reports including:
Investigational New Drug (IND) Annual Reports
Periodic Safety Update Reports (PSUR)
Periodic Benefit-Risk Evaluation Reports (PBRER)
Development Safety Update Reports (DSUR)
U.S. Periodic Safety Reports
Support the development and review of Risk Management Plans (RMP), Development Risk Management Plans, and Risk Evaluation and Mitigation Strategies (REMS).
Clinical Safety Governance
Provide medical oversight for safety monitoring committees and Data Safety Monitoring Board (DSMB) meetings.
Support integrated safety summaries and safety sections of Common Technical Documents (CTD).
Review project safety plans and medical monitoring plans for assigned studies.
Project and Stakeholder Collaboration
Serve as a medical safety consultant for pharmacovigilance case processing teams.
Participate in project meetings, client discussions, and cross-functional safety review sessions.
Present clinical safety findings and safety evaluations during stakeholder meetings.
Protocol and Clinical Documentation Review
Perform medical review of study protocols, Investigational Drug Brochures (IDB), and Case Report Forms (CRFs) to ensure appropriate safety data capture.
Support product labeling development and safety-related label updates.
Operational Oversight
Act as Global Safety Physician or backup safety physician for assigned projects when required.
Ensure timely delivery of safety deliverables within contractual and regulatory timelines.
Provide escalation support for pharmacovigilance and medical information activities.
Regulatory Compliance and Industry Awareness
Maintain awareness of evolving pharmacovigilance regulations, clinical research guidelines, and safety monitoring practices.
Ensure compliance with Good Clinical Practice (GCP) and global drug safety regulations.
Required Skills and Competencies
Strong knowledge of pharmacovigilance systems, safety reporting regulations, and drug safety evaluation.
In-depth understanding of clinical trials, pharmaceutical research, and drug development processes.
Experience reviewing safety data and preparing regulatory safety documentation.
Ability to analyze complex clinical safety data and assess benefit-risk profiles.
Strong organizational, analytical, and decision-making skills.
Ability to manage multiple safety projects while meeting strict deadlines.
Professional Qualifications
Medical degree (MD, MBBS, or equivalent) from a recognized medical institution.
Minimum 3 years of clinical practice experience such as postgraduate medical training.
Minimum 2 years of experience in the pharmaceutical, biotechnology, CRO, or healthcare industry.
Preferred Qualifications
Valid medical license or equivalent certification in the country of practice.
Experience in global pharmacovigilance operations and regulatory safety reporting.
Experience working with multinational clinical trials and global safety monitoring teams.
Why Join IQVIA
IQVIA offers healthcare professionals the opportunity to work on global drug development programs while contributing to patient safety and regulatory compliance. The organization provides exposure to advanced pharmacovigilance systems, international clinical trials, and collaborative research environments focused on improving healthcare outcomes.
Job Location
Thane, India (Home-Based / Remote Role)
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Birmingham |Virginia :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Richmond Hill | Mississauga | North York | Uxbridge | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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