Department: Pharmacovigilance and Clinical Research
Location: Hyderabad
Reporting To: Senior Vice President / Head of Pharmacovigilance
Qualifications and Experience
Education: MBBS or MD (mandatory)
Experience: Minimum 12+ years of progressive experience in pharmacovigilance, medical writing, and signal management within pharmaceutical, CRO, or healthcare organizations.
Proven leadership experience in managing cross-functional teams and client partnerships.
Role Overview
The General Manager – Pharmacovigilance & Medical Writing will lead client partnerships, ensure strategic and scientific excellence across safety deliverables, and oversee integrated PV and clinical documentation services. The role requires strong leadership, technical expertise, and client management skills to drive operational excellence and regulatory compliance.
Key Responsibilities
1. Client Relationship Management
Serve as the primary point of contact for assigned clients, ensuring exceptional service delivery and client satisfaction.
Develop a deep understanding of client goals, regulatory expectations, and therapeutic focus areas.
Coordinate cross-functional teams including Pharmacovigilance, Medical Writing, Clinical Operations, and Data Management to ensure seamless collaboration.
Lead regular client meetings, reviews, and presentations to track project progress, discuss deliverables, and identify opportunities for improvement.
Address and resolve client concerns promptly, escalating issues as necessary to maintain service quality and trust.
2. Pharmacovigilance Expertise
Provide strategic and subject matter expertise in pharmacovigilance and drug safety operations.
Oversee preparation, review, and quality assurance of aggregate safety reports including:
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Lead or support the preparation, maintenance, and submission of Risk Management Plans (RMPs) in accordance with global regulatory requirements.
Supervise signal detection and signal management activities, including data review, evaluation, and risk assessment documentation.
Deliver high-quality safety writing, such as responses to regulatory queries, benefit–risk assessments, and ad hoc reports.
Ensure all deliverables meet regulatory timelines, quality standards, and client expectations.
Demonstrate hands-on expertise in ICSR case processing with strong operational oversight and leadership capability.
3. Clinical Research Domain Support
Collaborate with clinical research and development teams to integrate pharmacovigilance requirements into:
Study protocols
Safety monitoring plans
Clinical trial documentation
Ensure PV deliverables are aligned with study timelines, regulatory milestones, and overall clinical development strategy.
Provide medical and safety insights to support protocol design, data interpretation, and clinical risk management.
Leadership and Strategic Contribution
Drive continuous improvement in PV and medical writing operations, focusing on innovation, automation, and compliance.
Mentor and develop cross-functional teams, fostering scientific excellence and accountability.
Contribute to business growth initiatives through client expansion, proposal support, and thought leadership.
Represent the organization in client audits, regulatory interactions, and global PV forums as needed.
Key Competencies
Strong leadership with a client-centric mindset.
In-depth understanding of global pharmacovigilance regulations (ICH, EMA, FDA).
Excellent scientific writing and review capabilities.
Proven ability to lead teams under pressure and meet critical deadlines.
Exceptional communication, stakeholder management, and decision-making skills.
High attention to quality, detail, and regulatory compliance.
Work Environment
Location: Hyderabad
Mode: Office-based
Dynamic, collaborative, and quality-driven environment with opportunities for strategic leadership and organizational growth.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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 :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
Bishop | Melbourne | Switzerland | Nairobi | Slovakia | Lenexa | Xzagreb | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Green Way | Remote, USA | Texas | Ireland | Springville | Hammond | Remote - South America (Latin Americal) | Zaragoza | Minnesota | Remote | Medan | French | Tulsa | Hungary | Faridabad | Remote - Middle East | Victoria | Lousiana | Thailand | Remote - Africa | Manipal | Castlebar | Riga | Leinster | Belgium | Bountiful | McFarland |Republic of Colombia :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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