Job Title:
Pharmacovigilance Officer, Team Leader (Line Management Position)
Location:
Belgrade, Serbia
Employment Type:
Full-time
Department:
ICSR Management
Company Overview:
PrimeVigilance, part of the Ergomed Group, is a specialised mid-size pharmacovigilance service provider established in 2008. With staff across Europe, North America, and Asia, we offer services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
We support small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships and establishing ourselves as a global leader.
PrimeVigilance invests in staff through excellent training, development programs, and promotes work-life balance, ensuring a high-quality client service environment.
Job Overview:
The Pharmacovigilance Officer, Team Leader, is responsible for overseeing and managing ICSR activities, ensuring compliance with regulations and client requirements. This role involves line management, mentoring, and providing support to PV processes within the department and for clients.
Key Responsibilities:
ICSR Management:
Process Individual Case Safety Reports (ICSRs) from all sources in compliance with regulations, procedures, and client requirements.
Perform ICSR follow-up, SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.
Perform clinical and partner reconciliation activities.
Ensure personal data protection and product quality complaint handling.
Interact with Medical Information as required.
Conduct MedDRA and WHO coding.
Generate database outputs and reports, including monthly client reporting.
Team Leadership & Mentoring:
Mentor and train new and junior staff within the department.
Manage workflow and resources effectively.
Support ICSR Subject Matter Experts (SMEs) and contribute as an ICSR SME.
PV Support & Compliance:
Support PV processes related to ICSR management for both PrimeVigilance and clients.
Act as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated countries/languages.
Support RA & PV Network Department as required.
Qualifications:
Life science graduate, pharmacy, nursing, or other healthcare-related qualification, or equivalent PV experience.
Extensive ICSR experience including mentoring and line management.
Excellent communication skills (written and verbal).
Strong organizational skills, attention to detail, multitasking, delegation, planning, and time management.
Technical proficiency and team-working ability.
Fluent in English (spoken and written).
Why Join PrimeVigilance:
Strong emphasis on training, career development, and personal/professional growth.
Friendly, supportive international working environment.
Opportunity to collaborate with colleagues worldwide, using English as the company language.
Company values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | 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 | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Pondicherry (Puducherry) |Punjab :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
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Finland |Hungary :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Basel | Zurich |Carlow :
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Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
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Sofia |Canada :
Canada |Ontario :
Uxbridge | Mississauga | Richmond Hill | Renfrew | Australia | North York |Quebec :
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North Ostrobothnia :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
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Brazil | Sao paulo |South America :
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