• Login / Signup
    • Instagram
    youtube
    Facebook

    Freelance / Consultant 0.5 Fte Local Contact Person For Pharmacovigilance And Regulatory Affairs (Lcppv/Lcpra)

    Primevigilance
    2+ years
    Not Disclosed
    Remote - Europe
    10 Nov. 19, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Freelance Local Contact Person for Pharmacovigilance and Regulatory Affairs (0.5 FTE)

    Company Description: PrimeVigilance, part of the Ergomed Group, is a specialized mid-sized pharmacovigilance service provider founded in 2008. We are proud of our continuous global organic growth, with teams across Europe, North America, and Asia. We offer expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, supporting pharmaceutical and biotechnology companies of all sizes. We provide global leadership in the field and cover a wide range of therapy areas, including medical devices.

    Job Description: We are seeking a freelancer/consultant to join us as the Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE. This position offers an exciting opportunity to work within an international team and expand your expertise in the broad and diverse fields of Pharmacovigilance (PV) and Regulatory Affairs.

    Main Responsibilities:

    • Act as the primary contact person for local regulatory authorities and provide pharmacovigilance expertise as required.
    • Maintain prompt and effective communication with local regulatory authorities.
    • Provide local regulatory intelligence screening and expert advice.
    • Collect and report locally suspected ADRs or ICSRs (Follow-ups, translations).
    • Oversee and manage local risk minimization measures related to urgent safety restrictions and emerging safety issues.
    • Review and provide linguistic input for local Product Information and Mock-ups.
    • Conduct local non-indexed literature screening and monitor Regulatory Authority websites for ADRs and safety information.
    • Support audits and inspections.
    • Handle local Quality Assurance tasks, such as suspected falsified products, quality alerts from Health Authorities (HA), and other market-specific quality requirements.

    Qualifications:

    • Bachelor’s Degree in Life Sciences, Chemistry, Nursing, or equivalent.
    • Proven experience within the pharmaceutical or CRO industry or regulatory bodies.
    • Experience in LCPPV / LCPRA roles is required.
    • PV training and/or working experience, or other educational qualifications as required by the local territory.
    • Expert knowledge of ICH GVP and relevant local legislation and requirements.
    • Proficiency in English (written and verbal) and the local language.
    • Strong skills in Microsoft Word, Excel, and PowerPoint.
    • Must be set up to work as a freelancer/consultant.

    Why PrimeVigilance? At PrimeVigilance, we foster diversity, equity, and inclusion, creating a work environment where people from all backgrounds, genders, and ages can thrive. Our success is driven by our people, and we believe in a human-first approach to improve lives around us.

    Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—guide how we work. If these values align with your own, PrimeVigilance could be the perfect company for you.

    We look forward to receiving your application!

    Latest Jobs

    Pharmacovigilance Reporting Specialist

    Icon
    Remote, USA

    Pharmacovigilance Services Assoc Manager

    Accenture
    Bangalore

    Senior Director (M/F/D) Medical Affairs Germany

    Teva Pharmaceuticals
    Ulm

    Pharmacovigilance Services Specialist

    Accenture
    Bangalore

    Medical Science Liaison - Midwest Territory

    Teva Pharmaceuticals
    Denver

    Director, Therapy Area Head, Global Regulatory Medical Writing (Usa, Remote)

    Teva Pharmaceuticals
    Parsippany

    Pharmacovigilance Services Associate

    Accenture
    Bengaluru

    Business Advisory Analyst

    Accenture
    Chennai

    Director, China Clinical Development Leader

    Teva Pharmaceuticals
    Shanghai Shi

    Business Advisory Associate

    Accenture
    Chennai

    Pharma Jobs in India

    Andra Pradesh :

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

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

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

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

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

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

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

    PAN-India :

    Panjab :

    Punjab :

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

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    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 | Wrangell |

    Arizona :

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

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | 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 York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    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 :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Australia & Colombia & Croatia & Egypt & England & Ireland & Israel & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Harlow | London | Salt Lake City |

    Republic of Ireland :

    Dublin | Limerick |

    Israel :

    Netanya | Tel Aviv | Kfar Saba |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

    Switzerland | Remote - Europe | Remote | Remote, USA |

    Makkah :

    Khulais | Rabigh | Riyadh | Jeddah | Najran |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |