• Login / Signup
    • Instagram
    youtube
    Facebook

    Executive - Pharmacovigilance Pv Psrm

    Apotex
    2-3 years years
    Preffered by Company
    Mumbai
    Not Disclosed July 9, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm, M.Pharm, PharmD, Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Executive - Pharmacovigilance PV PSRM

    Date: July 6, 2024
    Location: Mumbai, MH, IN, 400083
    Company: Apotex

    About Apotex Inc.

    Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. The Apotex group focuses on the development and sale of generic, biosimilar, and specialty products through vertical integration.
    For more information, visit: www.apotex.com.

    Job Summary

    The Executive - Pharmacovigilance PV PSRM prepares periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH Guidelines. The role involves using medical judgment to analyze and evaluate adverse reports, resolving causality assessment queries, and liaising with reporting sites. Additionally, the position participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

    Job Responsibilities

    Primary Responsibilities

    • Prepare periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
    • Maintain current awareness of safety issues on Apotex products through ongoing monitoring and literature review, demonstrating scientific skills in research, analysis, and interpretation of safety data.
    • Prepare responses to complex queries and requests for safety information from internal customers (RA, QA, NPD project teams, etc.).
    • Ensure adherence to compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

    Additional Responsibilities

    • Develop and maintain Standard Operating Procedures (SOPs).
    • Develop and maintain training documents and track compliance of internal and external global partners involved in drug safety reporting.
    • Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
    • Work as a team member to achieve all outcomes.
    • Deliver work in support of Apotex values: Collaboration, Courage, Perseverance, and Passion.
    • Perform other duties as assigned.

    Supporting Responsibilities

    • Provide input and feedback to departmental process improvement strategy discussions.
    • Contribute to creating and promoting an environment of teamwork, ensuring excellence in customer service through timely delivery of quality drug safety data.
    • Liaise regularly and develop strong working relationships with external partners and international Apotex affiliates, demonstrating corporate values in work performance and interactions.
    • Interact with other internal departments when necessary.
    • Contribute to the interpretation of PV regulations and apply sound decisions related to regulatory guidelines and policies.
    • Show initiative to remain current on new PV regulations and international guidelines, seeking guidance from Group Leader and management to enhance knowledge.
    • Perform all work in accordance with established ICH guidelines, regulatory compliance, and safety requirements, maintaining current knowledge of relevant Pharmacovigilance regulations.

    Job Requirements

    Education

    • Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline

    Knowledge, Skills, and Abilities

    • Excellent analytical and problem-solving skills
    • Excellent oral and written communication in English
    • Knowledge of MedDRA, Oracle ARGUS, and online literature searching (preferred)
    • Excellent organizational and interpersonal skills; experience in a dynamic team environment
    • Excellent knowledge of local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval
    • Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word

    Experience

    • Core PV experience with at least 2-3 years of pharmaceutical experience
    • Preferred experience of at least 1-2 years in periodic reviews on aggregate safety data

    Inclusion and Accommodation

    At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted for an interview or testing, please advise us if you require accommodation.

    Latest Jobs

    Drug Safety Associate I

    Parexel
    Mohali

    Pharmacovigilance Reporting Associate

    Icon
    Chennai

    Executive - Voice/Non Voice- Bhopal

    Hexaware Technologies
    Bhopal

    Pharmacovigilance Services Specialist

    Accenture
    Bengaluru

    Pharmacovigilance Services Specialist

    Accenture
    Bengaluru

    Pharmacovigilance Reporting Associate

    Icon
    Remote

    Medical Information Specialist

    Eversana
    Pune

    Medical Information Specialist

    Eversana
    Pune

    Serialization Analyst

    Eversana
    Pune

    Medical Reviewer

    Eversana
    Remote

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Eot Municipality | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji | Verna |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |

    Sikkim :

    Rangpo |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |

    Albama :

    Tuscaloosa |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    Arkansas :

    Fort Smith |

    California :

    Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Storrs | West Hartford |

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

    Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Lawrence | McPherson |

    Kenlucky :

    Louisville | Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Baton Rouge | Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maine :

    Bangor | Brewer |

    Maryland :

    Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |

    Massachusetts :

    Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh |

    New Hampshire :

    Lebanon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New Mexico :

    Farmington | Santa Fe | Tucumcari |

    New York :

    Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    northeastern :

    New Hampshire |

    Ohio :

    Cincinnati | Cleveland | Columbus, | Dayton | Erie | Macedonia | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |

    Pennsylvania :

    Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Brenham | Bulverde | Corpus Christi | Corsicana | Dallas | Fort Worth | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |

    United states :

    fairmont | Georgia | United States |

    United States :

    Hawai | Sylmar |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bellevue | Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |

    WI :

    Madison | Wausau |

    Wisconsin :

    Portage |

    Wyoming :

    Big Piney | Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Ingelheim am Rhein | Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    Latvia | Leuven | Poland | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    China :

    China |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Australia

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    South Holland :

    Leiden |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    Buenos Aires :

    Buenos Aires |

    Austria :

    Austria |

    Vienna :

    Vienna |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    Mississauga | Richmond Hill | Uxbridge | North York |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    United Kingdom | Leeds | Salt Lake City | London | Harlow | Maidenhead | Stirling |

    Estonia :

    Estonia | Tartu |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Athens | Koropi |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

    Be'Er Sheva | Kfar Saba | Netanya | Tel Aviv |

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote - Europe | Remote - Middle East | Remote, USA | Switzerland | Remote |

    Bucharest :

    Bucharest |

    Makkah :

    Najran | Rabigh | Khulais | Riyadh | King Abdullah Economic City | Jeddah |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |